U.S. patent application number 17/716533 was filed with the patent office on 2022-07-21 for systems and methods for phlebotomy through a peripheral iv catheter.
The applicant listed for this patent is VELANO VASCULAR, INC.. Invention is credited to Richard Thomas Briganti, Kenneth Todd Cassidy, Pitamber Devgon, Marc-Alan Levine, Mark Martel.
Application Number | 20220225915 17/716533 |
Document ID | / |
Family ID | 1000006252920 |
Filed Date | 2022-07-21 |
United States Patent
Application |
20220225915 |
Kind Code |
A1 |
Devgon; Pitamber ; et
al. |
July 21, 2022 |
Systems and Methods for Phlebotomy Through a Peripheral IV
Catheter
Abstract
An apparatus includes a catheter, an introducer having a first
member and a second member, a locking mechanism coupled to a distal
end of the first member and configured to couple the introducer to
a peripheral intravenous line, and an actuator coupled to the
catheter. The actuator is configured to move from a first
configuration, in which the catheter is disposed within the
introducer, toward a second configuration to move the second member
to a distal position relative to the first member. A portion of a
guide of the second member being distal to the first member when
the second member is in the distal position. The actuator is
configured to move relative to the second member to be placed in
the second configuration when the second member is in its distal
position such that the catheter is disposed within and extending
past an end of the peripheral intravenous line.
Inventors: |
Devgon; Pitamber;
(Philadelphia, PA) ; Briganti; Richard Thomas;
(Bala Cynwyd, PA) ; Cassidy; Kenneth Todd;
(Mocksville, NC) ; Levine; Marc-Alan; (Pottstown,
PA) ; Martel; Mark; (Winston-Salem, NC) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
VELANO VASCULAR, INC. |
San Francisco |
CA |
US |
|
|
Family ID: |
1000006252920 |
Appl. No.: |
17/716533 |
Filed: |
April 8, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16028120 |
Jul 5, 2018 |
11331023 |
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17716533 |
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|
14468826 |
Aug 26, 2014 |
10076272 |
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16028120 |
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|
13758585 |
Feb 4, 2013 |
9750446 |
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14468826 |
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13456900 |
Apr 26, 2012 |
8366685 |
|
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13758585 |
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13234857 |
Sep 16, 2011 |
9186100 |
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13456900 |
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61479223 |
Apr 26, 2011 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/150259 20130101;
A61B 5/150267 20130101; A61B 5/150221 20130101; A61B 5/150992
20130101; A61B 5/150946 20130101; A61B 5/150396 20130101; A61M
25/0606 20130101; A61B 5/150511 20130101; A61B 5/155 20130101; A61B
5/150526 20130101; A61B 5/154 20130101; A61M 2039/1077 20130101;
A61B 5/150717 20130101; A61M 39/02 20130101; A61M 2039/0202
20130101; A61B 5/150572 20130101; A61M 39/1011 20130101; A61B
5/15003 20130101 |
International
Class: |
A61B 5/15 20060101
A61B005/15; A61B 5/154 20060101 A61B005/154; A61M 39/02 20060101
A61M039/02; A61M 39/10 20060101 A61M039/10 |
Claims
1. An apparatus, comprising: a catheter having a proximal end
portion and a distal end portion, the catheter defining a lumen
extending through the proximal end portion and the distal end
portion of the catheter; an introducer defining an inner volume,
the introducer having a distal end portion configured to be coupled
to an indwelling peripheral intravenous line, the introducer
configured to transition between a first configuration, in which a
catheter protector is disposed within the introducer, and a second
configuration, in which at least a distal end portion of the
catheter protector is distal to the introducer and within the
indwelling peripheral intravenous line; and an actuator coupled to
the catheter and configured to transition the introducer between
the first configuration and the second configuration, at least the
distal end portion of the catheter being isolated within the
catheter protector and moving with the catheter protector as the
introducer is transitioned from the first configuration to the
second configuration, the actuator configured to move the catheter
relative to catheter protector when the introducer is in the second
configuration such that the distal end portion of the catheter is
distal to the catheter protector.
2. The apparatus of claim 1, wherein the catheter protector at
least partially encloses at least the distal end portion of the
catheter when the introducer is transitioned from the first
configuration to the second configuration.
3. The apparatus of claim 1, wherein the catheter protector is
disposed in a portion of the indwelling peripheral intravenous line
when the introducer is in the second configuration, and the
catheter protector is disposed between an outer surface of at least
the distal end portion of the catheter and an inner surface of the
portion of the indwelling peripheral intravenous line prior to the
catheter being moved relative to the catheter protector.
4. The apparatus of claim 1, wherein the actuator is maintained in
a fixed position relative to a portion of the introducer when the
actuator transitions the introducer from the first configuration to
the second configuration.
5. The apparatus of claim 1, wherein the actuator is maintained in
a fixed position relative to a portion of the introducer when the
actuator transitions the introducer from the first configuration to
the second configuration and the actuator is configured to move
relative to the portion of the introducer to move the catheter
relative to the catheter protector.
6. The apparatus of claim 1, wherein the catheter protector has a
first stiffness and the catheter has a second stiffness less than
the first stiffness.
7. The apparatus of claim 1, wherein a distal end surface of the
catheter protector is configured to be disposed within the
peripheral intravenous line when the introducer is in the second
configuration, the actuator is configured to move the catheter
relative to the catheter protector to place a distal end surface of
the catheter outside of and distal to the peripheral intravenous
line.
8. A method, comprising: coupling a fluid transfer device to a
peripheral intravenous line at least partially disposed within a
vein of a patient, the fluid transfer device including an
introducer, an actuator, and a catheter coupled to the actuator;
exerting a first force on the actuator to transition the introducer
from a first configuration, in which a catheter protector is
disposed within the introducer, to a second configuration, in which
at least a distal end portion of the catheter protector is distal
to the introducer and within the indwelling peripheral intravenous
line, at least the distal end portion of the catheter being
isolated within the catheter protector and moving with the catheter
protector as the introducer is transitioned from the first
configuration to the second configuration; exerting a second force
on the actuator to move the catheter relative to the catheter
protector such that a distal end portion of the catheter is distal
to the catheter protector; establishing fluid communication between
the catheter and a fluid reservoir; and withdrawing a volume of
bodily fluid from the patient into the fluid reservoir via the
catheter.
9. The method of claim 8, wherein the catheter protector at least
partially encloses at least the distal end portion of the catheter
when the introducer is transitioned from the first configuration to
the second configuration.
10. The method of claim 8, wherein the catheter protector is
disposed in a portion of the indwelling peripheral intravenous line
when the introducer is in the second configuration such that prior
to exerting the second force, the catheter protector is disposed
between an outer surface of at least the distal end portion of the
catheter and an inner surface of the portion of the indwelling
peripheral intravenous line.
11. The method of claim 8, wherein the catheter protector is
configured to limit contact between the catheter and an inner
portion of the indwelling peripheral intravenous line.
12. The method of claim 8, wherein exerting the second force on the
actuator to move the catheter relative to the catheter protector
places a distal end surface of the catheter within the vein of the
patient and distal to a distal end surface of the peripheral
intravenous line.
13. The method of claim 8, wherein coupling the fluid transfer
device to the peripheral intravenous line includes coupling the
fluid transfer device to an adapter such that the adapter is
disposed between the fluid transfer device and the peripheral
intravenous line.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. patent
application Ser. No. 16/028,120, entitled "Systems and Methods for
Phlebotomy Through a Peripheral IV Catheter", filed Jul. 5, 2018,
which is a continuation of U.S. patent application Ser. No.
14/468,826, entitled "Systems and Methods for Phlebotomy Through a
Peripheral IV Catheter", filed Aug. 26, 2014 (now U.S. Pat. No.
10,076,272), which is a continuation-in-part of U.S. patent
application Ser. No. 13/758,585, entitled "Systems and Methods for
Phlebotomy Through a Peripheral IV Catheter", filed Feb. 4, 2013
(now U.S. Pat. No. 9,750,446), which is a continuation of U.S.
patent application Ser. No. 13/456,900 entitled "Systems and
Methods for Phlebotomy Through a Peripheral IV Catheter", filed
Apr. 26, 2012 (now U.S. Pat. No. 8,366,685), which is a
continuation-in-part of U.S. patent application Ser. No.
13/234,857, entitled "Systems and Methods for Phlebotomy Through a
Peripheral IV Catheter", filed on Sep. 16, 2011 (now U.S. Pat. No.
9,186,100), which claims priority to U.S. Provisional Patent
Application Ser. No. 61/479,223, entitled "Systems and Methods for
Phlebotomy Through a Peripheral IV Catheter", filed on Apr. 26,
2011, the disclosures of which are incorporated herein by reference
in their entireties.
BACKGROUND
[0002] The embodiments described herein relate generally to medical
devices. More particularly, the embodiments described herein relate
to systems and methods for phlebotomy through an intravenous
catheter.
[0003] The typical hospitalized patient encounters a needle every
time a doctor orders a lab test. The standard procedure for blood
extraction involves using a metal needle ("butterfly needle") to
"stick" patients' veins in their arms or hands. Blood drawing is a
manual, labor-intensive process, with the average patient requiring
hours of direct skilled labor during a typical hospital stay. This
needle stick is not only painful and a major source of patient
dissatisfaction, but the nurses or specialized blood drawing
personnel (phlebotomists) often have difficulty finding the vein in
approximately 10-15% of patients, resulting in multiple, painful
"stick" attempts. This results in significantly higher material and
labor costs (needles and tubing must be disposed of after every
attempt) and increased patient pain and bruising.
[0004] The current process for drawing blood is inefficient, taking
on average 7-10 minutes, and more than 21 minutes for 10% of
patients. These 10% of patients are referred to as Difficult
Intra-Venous Access or more commonly as "tough stick" patients. If
superficial veins are not readily apparent, blood can be forced
into the vein by massaging the arm from wrist to elbow, tapping the
site with the index and middle finger, applying a warm, damp
washcloth to the site for 5 minutes, or by lowering the extremity
over the bedside to allow the veins to fill. Each of these methods
is time consuming and therefore costly.
[0005] Peripheral IV catheters (PIVs) are inserted into most
patients while they are hospitalized and used for infusing fluids
and medications. However, they are not designed for blood
extractions. The failure rates for aspiration reach 20-50% when
PIVs have been left inserted for more than a day. Blood extracted
from PIVs is often hemolyzed (e.g., defined as the rupture of red
blood cells and the release of their contents into surrounding
fluid) resulting in a discarded sample and the need to repeat the
blood collection.
[0006] There are several mechanical barriers that can contribute to
the shortcomings of extracting blood from a PIV. First, most
catheters are formed from a soft bio-reactive polymer, the use of
this material has led to a potential narrowing or collapse of the
catheter as the negative pressure is applied for aspiration or the
catheter is kinked during insertion or manipulation, preventing
backflow. Additionally, with longer indwelling times comes an
increase in debris (e.g., fibrin/platelet clots) that build up on
the tip of the catheter and within the lumen. This explains the
relationship between failure rate and indwelling time. A third
significant barrier is attributed to a "suction cup" effect,
wherein the negative pressure created by aspiration through the
catheter and the possible curved path of a vein result in the tip
of the catheter adhering to the wall of the vein. As the negative
pressure increases the vein can rupture resulting in "blowing the
vein," a major concern for phlebotomists during aspiration through
a PIV.
[0007] Thus, a need exists for an improved system and method for
phlebotomy through a peripheral intravenous catheter.
SUMMARY
[0008] Systems and methods for phlebotomy through a peripheral
intravenous catheter are described herein. In some embodiments, an
apparatus includes a catheter having a proximal end portion and a
distal end portion and defining a lumen therethrough, an introducer
having a first member and a second member, a locking mechanism
coupled to a distal end of the first member, and an actuator
coupled to the catheter. At least a portion of the second member is
movably disposed in the first member between a proximal position
and a distal position relative thereto. The second member includes
a guide having a distal end portion that is disposed in a distal
position relative to the first member when the second member is in
the distal position. The locking mechanism is configured to couple
the introducer to a peripheral intravenous line. At least a portion
of the actuator is disposed in the second member and is configured
to move from a first configuration toward a second configuration to
move the second member from its proximal position to its distal
position. The actuator is configured to move relative to the second
member to be placed in the second configuration when the second
member is in its distal position. The catheter is disposed within
the introducer when the actuator is in the first configuration and
is disposed within and extending past an end of the peripheral
intravenous line when in the actuator is in the second
configuration.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIGS. 1 and 2 are schematic illustrations of an apparatus in
a first configuration and a second configuration, respectively,
according to an embodiment.
[0010] FIG. 3 is a detailed schematic illustration of an apparatus
in a second configuration, according to an embodiment.
[0011] FIG. 4 is a detailed schematic illustration of an apparatus
in a second configuration, according to an embodiment.
[0012] FIGS. 5 and 6 are cross-sectional side views of an apparatus
in a first configuration and a second configuration, respectively,
according to an embodiment.
[0013] FIG. 6A is an enlarged view of a portion of the apparatus of
FIG. 6, indicated by the region X.
[0014] FIGS. 7 and 8 are cross-sectional side views of an apparatus
and an adapter in a first configuration and a second configuration,
respectively, according to an embodiment.
[0015] FIG. 9 is a perspective view of an apparatus in a first
configuration, according to an embodiment.
[0016] FIG. 10 is an exploded view of the apparatus illustrated in
FIG. 9.
[0017] FIG. 11 is a cross-sectional perspective view of the
apparatus illustrated in FIG. 9.
[0018] FIG. 12 is a perspective view of the apparatus illustrated
in FIG. 9, in a second configuration.
[0019] FIG. 13 is a cross-sectional perspective view of the
apparatus illustrated in FIG. 9, in the second configuration.
[0020] FIG. 13A is an enlarged view of a portion of the apparatus
of FIG. 13, indicated by the region Y.
[0021] FIG. 14 is a cross-sectional perspective view of the
apparatus illustrated in FIG. 9, in a third configuration.
[0022] FIGS. 15 and 16 are a side view of an apparatus in a first
configuration and a second configuration, respectively, according
to an embodiment.
[0023] FIG. 17 is a perspective view of the apparatus illustrated
in FIG. 15, in the second configuration.
[0024] FIG. 18 is an exploded side view of the apparatus of FIG. 15
and an adapter, according to an embodiment.
[0025] FIG. 19 is a side view of the apparatus and adapter
illustrated in FIG. 18, in a first configuration.
[0026] FIG. 20 is a side view of the apparatus and the adapter
illustrated in FIG. 18, in a second configuration.
[0027] FIG. 21 is a perspective view of the apparatus illustrated
in FIG. 18, in the second configuration.
[0028] FIG. 22 is an enlarged view of a portion of the apparatus of
FIG. 18, indicated by the region Z in FIG. 21.
[0029] FIGS. 23 and 24 are schematic illustrations of an apparatus
in a first configuration and a second configuration, according to
an embodiment.
[0030] FIGS. 25 and 26 are schematic illustrations of an apparatus
in a first configuration and a second configuration, according to
an embodiment.
[0031] FIGS. 27 and 28 are schematic illustrations of an apparatus
in a first configuration and a second configuration, according to
an embodiment.
[0032] FIGS. 29-37 are side views of various catheter
configurations included in an apparatus, according to an
embodiment.
[0033] FIGS. 38-43 are various views of two-port adapters,
according to various embodiments.
[0034] FIGS. 44 and 45 are views of single-port adapters, according
to embodiments.
[0035] FIG. 46 is a flowchart illustrating a method of phlebotomy
through a peripheral intravenous line, according to an
embodiment.
[0036] FIG. 47 is a perspective view of a fluid transfer device
according to another embodiment.
[0037] FIG. 48 is an exploded view of the fluid transfer device of
FIG. 47.
[0038] FIG. 49 is a perspective view of a first introducer member
included in the fluid transfer device of FIG. 47.
[0039] FIG. 50 is a cross-sectional view of the first introducer
member taken along the line 50-50 in FIG. 49.
[0040] FIG. 51 is a cross-sectional view of the first introducer
member taken along the line 51-51 in FIG. 50.
[0041] FIG. 52 is a cross-sectional view of the first introducer
member taken along the line 52-52 in FIG. 50.
[0042] FIG. 53 is a perspective view of a second introducer member
included in the fluid transfer device of FIG. 47.
[0043] FIG. 54 is a cross-sectional view of the second introducer
member taken along the line 54-54 in FIG. 53.
[0044] FIG. 55 is a cross-sectional view of the first introducer
member taken along the line 50-50 in FIG. 49 and the second
introducer member taken along the line 54-54 in FIG. 53.
[0045] FIG. 56 is a perspective view of an actuator included in the
fluid transfer device of FIG. 47.
[0046] FIG. 57 is a cross-sectional view of the actuator taken
along the line 57-57 in FIG. 56.
[0047] FIG. 58 is a rear view of the fluid transfer device of FIG.
47.
[0048] FIG. 59 is a cross-sectional view of the fluid transfer
device taken along the line 59-59 in FIG. 58, in a first
configuration.
[0049] FIG. 60 is an enlarged view of a portion of the fluid
transfer device of FIG. 59 indicated by the region A.sub.1.
[0050] FIG. 61 is an enlarged view of a portion of the fluid
transfer device of FIG. 59 indicated by the region A.sub.2.
[0051] FIG. 62 is an enlarged view of a portion of the fluid
transfer device of FIG. 59 indicated by the region A.sub.3.
[0052] FIG. 63 is a cross-sectional view of the fluid transfer
device taken along the line 59-59 in FIG. 58, in a second
configuration.
[0053] FIG. 64 is an enlarged view of a portion of the fluid
transfer device of FIG. 63 indicated by the region A.sub.4.
[0054] FIG. 65 is a cross-sectional view of the fluid transfer
device taken along the line 59-59 in FIG. 58, in a third
configuration.
[0055] FIG. 66 is an enlarged view of a portion of the fluid
transfer device of FIG. 65 indicated by the region A.sub.5.
[0056] FIGS. 67 and 68 are cross-sectional views of the fluid
transfer device of FIG. 47 taken along the line 67-67, in the third
configuration and a fourth configuration, respectively.
[0057] FIG. 69 is a top view of a first member of an introducer
according to another embodiment.
[0058] FIG. 70 is a rear view of the first member of FIG. 69.
[0059] FIG. 71 is a cross-sectional view of the first member taken
along the line 71-71 in FIG. 70.
[0060] FIG. 72 is an enlarged view of a portion of the first member
identified in FIG. 71 by the region A.sub.6.
[0061] FIG. 73 is a top view of an actuator according to another
embodiment.
[0062] FIG. 74 is a rear view of the actuator of FIG. 73.
[0063] FIG. 75 is a cross-sectional view of the actuator taken
along the line 75-75 in FIG. 74.
[0064] FIG. 76 is an enlarged view of a portion of the actuator
identified in FIG. 75 by the region A.sub.7.
[0065] FIG. 77 is a flowchart illustrating a method of phlebotomy
through a peripheral intravenous line, according to another
embodiment.
[0066] FIGS. 78 and 79 are schematic illustrations of a distal end
portion of a catheter according to different embodiments.
DETAILED DESCRIPTION
[0067] Systems and methods for phlebotomy through a peripheral
intravenous catheter are described herein. In some embodiments, an
apparatus includes a catheter having a proximal end portion and a
distal end portion and defining a lumen therethrough, an introducer
having a first member and a second member, a locking mechanism
coupled to a distal end of the first member, and an actuator
coupled to the catheter. At least a portion of the second member is
movably disposed in the first member between a proximal position
and a distal position relative thereto. The second member includes
a guide having a distal end portion that is disposed in a distal
position relative to the first member when the second member is in
the distal position. The locking mechanism is configured to couple
the introducer to a peripheral intravenous line. At least a portion
of the actuator is disposed in the second member and is configured
to move from a first configuration toward a second configuration to
move the second member from its proximal position to its distal
position. The actuator is configured to move relative to the second
member to be placed in the second configuration when the second
member is in its distal position. The catheter is disposed within
the introducer when the actuator is in the first configuration and
is disposed within and extending past an end of the peripheral
intravenous line when in the actuator is in the second
configuration.
[0068] In some embodiments, an apparatus includes a catheter, a
first introducer, a second introducer, and an actuator. The
catheter has a proximal end portion and a distal end portion and
defining a lumen therethrough. The first introducer has a proximal
end portion, a distal end portion, and an inner surface defining a
channel. The distal end portion of the first introducer is
configured to be coupled to a peripheral intravenous line. The
second introducer has a proximal end portion and a distal end
portion. The distal end portion of the second introducer includes a
guide member. At least a portion of the second introducer is
movably disposed in the first introducer such that a protrusion
extending from an outer surface of the second introducer is
disposed in the channel. The second introducer has a range of
motion relative to the first introducer defined at least in part by
the channel. The actuator is coupled to the catheter and is at
least partially disposed in the second introducer. The actuator is
configured to move the second introducer through at least a portion
of the range of motion to advance a distal end portion of the guide
member through the peripheral intravenous line. The actuator is
configured to move from a first position relative to the second
introducer, in which the catheter is disposed in the guide member,
to a second position relative to the second introducer, in which
the distal end portion of the catheter extends beyond a distal end
of the guide member.
[0069] In some embodiments, a method includes coupling a fluid
transfer device to a peripheral intravenous line. The fluid
transfer device includes an introducer having a first member and
second member. The second member includes a guide member and is
movably disposed in the first member. The fluid transfer device
includes an actuator movably disposed in the second member and a
catheter coupled to the actuator. A first force is exerted on the
actuator. The first force is sufficient to move the second member
relative to the first member from a first position, in which the
guide member is disposed in the first member, to a second position,
in which a distal end portion of the guide member is inserted
through a port of the peripheral intravenous line. A second force
is exerted on the actuator. The second force is sufficient to move
the actuator relative to the second member when the second member
is in the second position to advance the catheter from a first
position, in which the catheter is disposed in the introducer, to a
second position, in which a distal end portion of the catheter
extends past an end of the peripheral intravenous line. A fluid
reservoir is coupled to the fluid transfer device such that the
fluid reservoir is fluidically coupled to the catheter. The
catheter is withdrawn from the peripheral intravenous line after a
volume of bodily fluid is transferred to the fluid reservoir such
that the catheter is disposed within the introducer.
[0070] In some embodiments, an apparatus includes a cannula or
catheter, an introducer, a locking mechanism, and an actuator. The
catheter includes a proximal end and a distal end and defines a
lumen. The introducer includes a proximal end and a distal end and
defines a lumen configured to receive at least a portion of the
catheter. The locking mechanism is coupled to the distal end of the
introducer and is configured to couple the introducer to a
peripheral intravenous line. The actuator is operatively coupled to
the catheter and is configured to move the catheter between a first
configuration, in which the catheter is substantially within the
introducer, and a second configuration, in which the catheter is
substantially outside the introducer. The catheter extends past an
end of the peripheral intravenous line when in the second
configuration.
[0071] In some embodiments, a method includes coupling an
introducer to a peripheral intravenous line (e.g., saline locked
device, heparin locked device, or the like), the introducer having
a proximal end and a distal end. The method further includes
advancing a catheter from a first position inside the introducer
and outside the peripheral intravenous line to a second position
substantially outside the introducer and inside the peripheral
intravenous line. In some embodiments, the catheter has a length
greater than a length of the peripheral intravenous line, while in
other embodiments, the catheter, in the second position, is shorter
than the peripheral intravenous line. The method includes coupling
a container to the proximal end of the introducer such that the
container is fluidically coupled to the catheter. The method
further includes withdrawing the catheter from the second position
to the first position.
[0072] In some embodiments, a catheter has a proximal end and a
distal end and defines a lumen therethrough. An introducer has a
proximal end and a distal end and defines a lumen therethrough. The
introducer is configured to receive the catheter therein. An
adapter is coupled to the introducer. The adapter has a distal end
configured to be coupled to a peripheral intravenous line. The
adapter defines a first lumen and a second lumen. The first lumen
has a first diameter and is configured to receive the catheter
therethrough. The second lumen is orthogonal to the first lumen. An
actuator is operatively coupled to the catheter and is configured
to move the catheter between a first configuration and a second
configuration. The catheter extends past the distal end of the
adapter in the second configuration.
[0073] As used herein, the terms "catheter" and "cannula" are used
interchangeably to describe an element configured to define a
passageway for moving a bodily fluid from a first location to a
second location (e.g., a fluid passageway to move a bodily fluid
out of the body). While cannulas can be configured to receive a
trocar, a guide wire, or an introducer to deliver the cannula to a
volume inside the body of a patient, the cannulas referred to
herein need not include or receive a trocar, guide wire, or
introducer.
[0074] As used in this specification, the terms "Y-adapter" and
"T-adapter" are used to refer to a dual port IV extension set. In
this manner, the terms "Y-adapter" and "T-adapter" generally
describe an overall shape of the dual port IV extension set. For
example, as used herein, a Y-adapter is substantially "Y" shaped
including a single port at a first end and two ports angularly
disposed at a second end. Furthermore, the terms "Y-adapter" and
"T-adapter" are included by way of example only and not limitation.
For example, in some embodiments, an apparatus can include a single
port IV extension set (e.g., a single port adapter) or a multi-port
IV extension set (e.g., an adapter with more than two ports).
[0075] As used in this specification, the words "proximal" and
"distal" refer to the direction closer to and away from,
respectively, a user who would place the device into contact with a
patient. Thus, for example, the end of a device first touching the
body of the patient would be the distal end, while the opposite end
of the device (e.g., the end of the device being manipulated by the
user) would be the proximal end of the device.
[0076] As used herein, the term "stiffness" relates to an object's
resistance to deflection, deformation, and/or displacement by an
applied force. Stiffness can be characterized in terms of the
amount of force applied to the object and the resulting distance
through which a first portion of the object deflects, deforms,
and/or displaces with respect to a second portion of the object.
When characterizing the stiffness of an object, the deflected
distance may be measured as the deflection of a portion of the
object different from the portion of the object to which the force
is directly applied. Said another way, in some objects, the point
of deflection is distinct from the point where force is
applied.
[0077] Stiffness is an extensive property of the object being
described, and thus is dependent upon the material from which the
object is formed as well as certain physical characteristics of the
object (e.g., shape and boundary conditions). For example, the
stiffness of an object can be increased or decreased by selectively
including in the object a material having a desired modulus of
elasticity, flexural modulus, and/or hardness. The modulus of
elasticity is an intensive property of (i.e., is intrinsic to) the
constituent material and describes an object's tendency to
elastically (i.e., non-permanently) deform in response to an
applied force. A material having a high modulus of elasticity will
not deflect as much as a material having a low modulus of
elasticity in the presence of an equally applied stress. Thus, the
stiffness of the object can be increased, for example, by
introducing into the object and/or constructing the object of a
material having a high modulus of elasticity.
[0078] Similarly, a material's hardness is an intensive property of
the constituent material and describes the measure of how resistant
the material is to various kinds of permanent shape change when a
force is applied. In discussing the hardness and the subsequent
effect on the stiffness of a catheter, the Shore durometer scale is
generally used. There are several scales for durometers with two
commonly used in describing plastics, polymers, elastomers, and/or
rubbers, namely, type A and type D, where type A is generally used
for softer materials and type D is generally used for harder
materials. The Shore durometer of a material is denoted by a number
between 0 and 100, with higher numbers indicating a harder
material, followed by the type of scale. For instance, a first
material can be measured as having a Shore durometer of 40 Shore A
and a second material can be measured as having a Shore durometer
of 60 Shore D. Therefore, according to the Shore durometer scale,
the second material is harder and thus, more stiff than the first
material.
[0079] FIGS. 1 and 2 are schematic illustrations of an apparatus
1000 for phlebotomy through a peripheral intravenous line or
catheter in a first configuration and second configuration,
respectively, according to an embodiment. The apparatus 1000
includes an introducer 1100, a cannula or catheter 1200, a lock
mechanism 1131, and an actuator 1500. The introducer 1100 includes
a sheath 1110 having a proximal end 1120 and a distal end 1130 and
defining a lumen 1113. The catheter/cannula 1200 is movably
disposed within sheath 1110 between the proximal end 1120 and the
distal end 1130.
[0080] The proximal end 1120 includes a port 1121, such that the
catheter/cannula 1200 can move from the first, retracted
configuration (FIG. 1) to the second, extended configuration (FIG.
2). Similarly stated, the port 1121 at the proximal end 1120 of the
introducer 1100 is configured such that the catheter 1200 may move
through the port 1121 from the first configuration to the second
configuration. The port 1121 can be any suitable port such as, for
example, an opening in the proximal end 1120 of the introducer
1100. Furthermore, the port 1121 can include any suitable seal
member such as an O-ring or a gasket. In some embodiments, the port
1121 can be a self-sealing port and can be lubricated using any
suitable lubrication to aid in the movement and/or sealing of the
catheter 1200 therein.
[0081] The distal end 1130 of the introducer 1100 includes a
locking mechanism 1131 configured to fluidically couple a
peripheral intravenous line 1300 to the introducer 1100 and place
the catheter 1200 into fluid communication with the peripheral
intravenous line 1300. The locking mechanism 1131 can be any
suitable locking mechanism that creates a fluid-tight seal. In some
embodiments, the locking mechanism can be a Luer Lok.TM. or similar
configuration. In some embodiments, the peripheral intravenous line
1300 is in a sealed configuration until the locking mechanism 1131
is coupled to the intravenous line 1300. Once the locking mechanism
1131 is coupled to the intravenous line 1300, the seal can be
opened to allow access for the catheter 1200. In some embodiments,
the locking mechanism can include a back flow prevention mechanism
such as a one-way valve or the like. In this manner, the lock
mechanism 1131 can be configured to allow the catheter 1200 to pass
through the lock mechanism 1131 but substantially prevent a fluid
flow, outside the catheter 1200, through the lock mechanism
1131.
[0082] The catheter 1200 defines a lumen 1201 between a proximal
end 1220 and a distal end 1230 and may be any suitable diameter and
stiffness. In some embodiments, the catheter 1200 can be between a
16-gauge and 26-gauge and have a Shore durometer of approximately
20 Shore A to 50 Shore D. In some embodiments, the catheter 1200
has a Shore durometer of approximately 20 Shore A to 95 Shore D. In
some embodiments, the catheter 1200 has a Shore durometer of
approximately 70 Shore D to 85 Shore D. In this manner, the
catheter 1200 can be any suitable diameter to be inserted through
the peripheral intravenous line 1300 and can be sufficiently stiff
to be advanced through the peripheral intravenous line 1300.
[0083] The actuator 1500 is operatively coupled to the catheter
1200 through a groove or slot 1111 in the introducer 1100. The
actuator 1500 is configured to move the catheter 1200 from the
first configuration to the second configuration such that the
distal end 1230 of the catheter 1200 is substantially outside the
introducer 1100, as shown in FIG. 2. In some embodiments, the
length of the distal end 1230 of the catheter 1200 is greater than
the length of the peripheral intravenous line 1300. In this manner,
the distal end 1230 of the catheter 1200 extends past the distal
end of the intravenous line 1300.
[0084] In some embodiments, the catheter 1200 can be moved to a
third configuration in which the catheter 1200 is retracted back
into the introducer 1100. The third configuration can be
substantially similar to the first configuration (FIG. 1) in that
the catheter 1200 is positioned in the introducer 1100, thus, the
user does not come into contact with bodily fluids. While in the
first configuration and the third configuration, the apparatus 1000
can be disconnected from or connected to a peripheral intravenous
line 1300. Said another way, the apparatus 1000 can be in the first
configuration before it is coupled to the peripheral intravenous
line 1300, then remain in the first configuration for a period of
time after being coupled to the peripheral intravenous line 1300.
Similarly, the apparatus 1000 can be moved to the third
configuration, be disconnected from the peripheral intravenous line
1300, and then remain in the third configuration.
[0085] FIG. 3 is a detailed schematic illustration of an apparatus
2000 according to an embodiment in a second configuration. In some
embodiments, the apparatus 2000 is substantially similar to the
apparatus 1000 described above in reference to FIGS. 1 and 2.
Therefore, aspects of the apparatus 2000 are not described in
detail herein. The apparatus 2000 includes an introducer 2100 and a
catheter 2200. The catheter 2200 includes a proximal end 2220 and a
distal end 2230. The distal end 2230 of the catheter 2200 includes
a set of openings 2231 such that when in the second configuration
(e.g., when the distal end 2230 of the catheter 2200 is in the vein
and outside the intravenous line) the openings 2231 act to
transport a bodily fluid (e.g., blood) to a volume outside the
catheter 2200. The set of openings 2231 can be of any arrangement
on the circumference of the catheter 2200 and can include the end
of the catheter 2200. Similarly stated, the catheter 2200 having
the distal end 2230 can define an opening at the tip surface. Each
opening 2231 can be of any suitable shape or size and are not
necessarily similar to any other opening included in the set of
openings 2231. In some embodiments, the catheter 2200 defines a
single opening. For example, in some embodiments, the catheter 2200
defines a single opening 2231 at the distal surface.
[0086] The proximal end 2220 of the catheter 2200 is fluidically
coupled to a locking mechanism 2221, as shown in FIG. 3. The
locking mechanism 2221 can be any suitable locking mechanism such
as a Luer Lok.TM. or the like. A needle 2222 is fluidically coupled
to the locking mechanism 2221 and at least partially disposed
within a sheath 2223. The sheath 2223 can be any material with a
suitable flexibility and/or compressibility such that the needle
2222 can extend through the sheath 2223 when engaged with a
conventional phlebotomy fluid container (e.g., a Vacutainer.RTM.).
The locking mechanism 2221 is configured to be coupled to any
suitable fluid containment system such as a Vacutainer.RTM. holder
(not shown in FIG. 3) and place the needle 2222 in fluid
communication with the fluid containment system. The sheath 2223 is
configured to compress when the locking mechanism 2221 is coupled
to the fluid containment system. This arrangement facilitates the
passage of bodily fluids through the set of openings 2231 of the
catheter 2200, as shown in FIG. 3 by arrow AA, through the catheter
2200, and exiting the catheter 2200 through the needle 2222, as
shown in FIG. 3 by arrow BB.
[0087] FIG. 4 is a schematic illustration of an apparatus 3000 for
phlebotomy through a peripheral intravenous catheter in a second
configuration according to an embodiment. The apparatus 3000
includes an introducer 3100 and a catheter 3200. The introducer
3100 includes a sheath 3110 defining a lumen 3113 between a
proximal end 3120 and a distal end 3130 and configured to house, at
least partially, the catheter 3200. The distal end 3130 of the
introducer 3100 includes a locking mechanism 3131 configured to
fluidically couple the introducer 3100 to a peripheral intravenous
line 3300 and place the catheter 3200 into fluid communication with
the peripheral intravenous line 3300, when the catheter 3200 is in
the second configuration. The locking mechanism 3131 can be any
suitable locking mechanism that creates a fluid-tight seal. In some
embodiments, the locking mechanism 3131 can be a Luer Lok.TM. or
similar configuration. The sheath 3110, having a given stiffness,
is configured such that when applying a force to the proximal end
3120 (as indicated by the arrow CC in FIG. 4), the sheath 3110
compresses along an axis AAA.
[0088] The compression of the sheath 3110 is such that the catheter
3200 is advanced to the second configuration. Said another way, as
the sheath 3110 of the introducer 3100 is compressed, the catheter
3200 moves from a first configuration where in the catheter 3200 is
disposed within the introducer 3100 (as described above with
respect to FIG. 1) to a second configuration wherein the distal end
3230 is substantially outside the introducer 3100, as shown in FIG.
4. Furthermore, the stiffness of the sheath 3110 is an extensive
property and as such can have a set of properties (i.e. material,
thickness, shape and/or the like) to allow the sheath 3110 to
compress along the axis AAA with the desired amount of force
applied at the proximal end 3120 of the introducer 3100. The set of
properties allow the sheath 3110 to elastically deform (i.e.
non-permanently) such that when the force is no longer applied to
the proximal end 3120 of the introducer 3100, the apparatus 3000
returns to the first configuration. In the second configuration,
the distal end 3230 of the catheter 3200 extends past the distal
end of the peripheral intravenous line 3300. This arrangement
allows for the transport of a bodily fluid to a volume outside the
catheter 3200 and when complete, the apparatus 3000 can be placed
in a third configuration, substantially similar to the first
configuration.
[0089] FIGS. 5 and 6 are side views of an apparatus 4000 according
to an embodiment in a first configuration and a second
configuration, respectively. The apparatus 4000 includes an
introducer 4100 and a catheter 4200. The introducer 4100 includes a
sheath 4110 defining a lumen 4113 between a proximal end 4120 and a
distal end 4130 and is configured to house, at least partially, the
catheter 4200. Although shown in FIG. 5 as being cylindrical, the
introducer 4100 can be any suitable shape. Moreover, the lumen
4113, defined by the interior walls of the sheath 4110 is not
necessarily the same shape as the exterior walls of the sheath
4110. Said a different way, the interior and exterior walls of the
sheath 4110 can have a different cross sectional shape. The
proximal end 4120 of the introducer 4100 is coupled to a locking
mechanism 4122. The locking mechanism 4122 can be any suitable
locking mechanism such as a Luer Lok.TM. or the like. In use, the
locking mechanism 4122 is configured to couple to a suitable fluid
containment system such as a Vacutainer.RTM. holder (not shown in
FIG. 5) to place the catheter 4200 in fluid communication with the
fluid containment system.
[0090] The distal end 4130 of the introducer 4100 includes a
locking mechanism 4131 configured to fluidically couple the
introducer 4100 to a peripheral intravenous line (not shown in FIG.
5). In this manner, the locking mechanism 4131 can be configured to
selectively place the catheter 4200 into fluid communication with
the peripheral intravenous line. The locking mechanism 4131 can be
any suitable locking mechanism that creates a fluid-tight seal. In
some embodiments, the locking mechanism 4131 is in a sealed
configuration until the locking mechanism 4131 is coupled to the
intravenous line. Once the locking mechanism 4131 is coupled to the
intravenous line, the seal can be opened to allow access for the
catheter 4200. In addition, while in the unlocked configuration,
the locking mechanism 4131 of the distal end 4130 and the locking
mechanism 4122 of the proximal end 4120 create a fluidically
isolated housing for the catheter 4200 therein. Stated similarly,
prior to the proximal end locking mechanism 4122 and distal end
locking mechanism 4131 being unlocked and before the catheter 4200
is in the second configuration, the catheter 4200 is sterile.
Furthermore, the catheter 4200, when in the second configuration
and having contacted the desired bodily fluid, can be moved to a
third configuration (e.g., substantially similar to the first
configuration) thereby isolating the used distal end 4230.
[0091] The sheath 4110 has a given stiffness such that when a force
(as indicated by the arrow DD in FIG. 6) is applied to the proximal
end 4120, the sheath 4110 compresses along an axis BBB. The
compression of the sheath 4110 is such that the catheter 4200 is
advanced to the second configuration. Said another way, as the
sheath 4110 of the introducer 4100 is compressed, the catheter 4200
moves from the first configuration wherein the catheter 4200 is
disposed within the introducer 4100 to the second configuration
wherein the distal end 4230 is substantially outside the introducer
4100 (e.g., the sheath 4110 retracts). The properties of the sheath
4110 can be any set of properties discussed herein such that
applying a desired amount of force to proximal end 4120 allows the
sheath to compress along axis BBB. In the second configuration, the
distal end 4230 of the catheter 4200 extends past the distal end of
the peripheral intravenous line and allows for the transport of a
bodily fluid to a volume outside of the catheter 4200.
[0092] The catheter 4200 includes a distal end 4230 and tapered
portion 4203. The tapered portion is such that the diameter of the
catheter 4200 is reduced at a given location, as shown in FIG. 5.
The taper angle .theta. can be any suitable angle such that the
catheter 4200 is allowed to advance fully to the second
configuration (FIG. 6). Moreover, the taper angle .theta. is such
that a laminar flow (i.e., smooth layered flow) is achieved. In
some embodiments, the catheter 4200 can include a stiffening wire
4202, as shown in FIG. 6A, and can be configured to coil around the
walls of the catheter 4200 providing the catheter 4200 with a
desired stiffness. Moreover, the stiffening wire 4202, being coiled
around the catheter 4200, can provide the flexibility to advance
through a set of walls defining a lumen (i.e., veins, arteries,
peripheral intravenous line, and/or the like) without kinking or
binding. In addition, the stiffening wire 4202 can provide the
catheter 4200 with enough stiffness to facilitate its advancement
through the lumen.
[0093] The distal end 4230 of the catheter 4200 includes a set of
openings 4231 such that when in the second configuration (e.g.,
when the distal end 4230 of the catheter 4200 is in the vein and
outside the intravenous line) the openings 4231 act to transport a
bodily fluid (i.e., blood) to a volume outside the catheter 4200.
The set of openings 4231 can be of any arrangement on the
circumference of the catheter 4200 and can include the end of the
catheter 4200. Similarly stated, the catheter 4200 having the
distal end 4230 can be substantially open at the tip surface.
Although FIGS. 6 and 6A show the distal end 4230 of the catheter
4200 as substantially flat, the distal end 4230 may be any suitable
shape, (e.g. conical or spherical) and can have any suitable degree
of rounded edges. Each opening 4231 can be of any suitable shape or
size and are not necessarily similar to any other opening 4231
included in the set of openings 4231. The arrangement of the set of
openings 4231 is configured to introduce a laminar flow through
catheter 4200 to a volume substantially outside the catheter 4200
and thus avoid hemolysis.
[0094] In some embodiments, a blood collection system consists of
two elements: (1) the introducer/catheter blood collection assembly
described above; and (2) a y-adapter that is configured to attach
to a standard 16g or 22g peripheral IV catheter. The y-adapter
includes a dedicated port for the blood collection device and
another standard port for conventional medicine and fluid
infusion.
[0095] For example, FIG. 7 includes a cross-sectional view of a
y-adapter 5400 and an apparatus 5000 in a first configuration,
according to an embodiment. The apparatus 5000 includes an
introducer 5100 and a catheter 5200. The introducer 5100 includes a
sheath 5110 defining a lumen 5113 between a proximal end 5120 and a
distal end 5130 and configured to house, at least partially, the
catheter 5200. The catheter 5200 includes a proximal end 5220 and a
distal end 5230. The apparatus 5000 can be substantially similar to
the apparatus 4000 described above with reference to FIGS. 5 and 6.
Therefore, aspects of the apparatus 5000 are not described in
further detail herein.
[0096] In some embodiments, the y-adapter 5400 is configured to be
coupled between the introducer 5100 and intravenous line 5440. The
y-adapter includes a distal end 5410 and defines a first port 5420
and a second port 5430. The first port 5420 of the y-adapter 5400
defines a first lumen 5422 with a first diameter D.sub.1. The first
port 5420 is configured such that the first port 5420 is
substantially similar in size, shape, configuration, and
functionality of a conventional y-adapter. Moreover, the first port
5420 is configured such that the backflow of a bodily fluid cannot
exit the first port 5420. More specifically, the first lumen 5422
defined by the walls of the first port 5420 can be such that the
lumen 5422 restricts the backflow of a bodily fluid (i.e. blood).
In some embodiments, the backflow can be prevented using a valve,
screw cap, flip cap, port, and/or the like.
[0097] The second port 5430 of the y-adapter 5400 defines a second
lumen 5432 with a second diameter D.sub.2. As shown in FIG. 7, the
second diameter D.sub.2 can be configured to be larger than first
diameter D.sub.1. In other embodiments, the second diameter D.sub.2
can be similar or smaller than the first diameter D.sub.1. More
particularly, the diameter D.sub.2 of the second port 5430 is large
enough to accept up to, for example, an 18-gauge catheter. The
y-adapter 5400 can be of any suitable material and/or be of similar
material to that of a conventional y-adapter.
[0098] The first lumen 5422 defined by the first port 5420 and the
second lumen 5432 defined by the second port 5430 converge to a
common lumen 5401 before the distal end 5410 of the y-adapter 5400,
as shown in FIG. 7. The second port 5430 is configured such that
the second lumen 5432 is substantially coaxial with the common
lumen 5401. Furthermore, the common lumen 5401 can have a diameter
substantially similar to the diameter D.sub.2 of the second port
5430.
[0099] The second port 5430 is fluidically coupled to a locking
mechanism 5431 configured to couple the y-adapter to the introducer
5100. The locking mechanism 5431 can be a Luer Lok.TM. or the like.
In some embodiments, the y-adapter 5400 is in a sealed
configuration until coupled to the locking mechanism 5131 at the
distal end 5130 of the introducer 5100. Once the locking mechanism
5431 is coupled to the introducer 5100, the seal can be opened to
allow access for the catheter 5200 to advance to a second
configuration, shown in FIG. 8 (note the introducer 5100 is not
shown coupled to the y-adapter in FIG. 8).
[0100] In some embodiments, the distal end 5410 of the y-adapter
5400 is coupled to a peripheral intravenous line 5440 such as, for
example, a conventional peripheral intravenous line. In some
embodiments, the y-adapter 5400 is monolithically formed with the
peripheral intravenous line 5440. In some embodiments, the distal
end 5410 of the y-adapter 5400 can be coupled to a peripheral
intravenous line using any suitable locking mechanism. Similarly,
the second port 5420 of the locking mechanism 5431 configured to
couple the y-adapter 5400 to the introducer 5100 can monolithically
formed with the introducer 5100. Said another way, in some
embodiments, a separate introducer is not required, but rather a
portion of the y-adapter can serve as the introducer.
[0101] When in the second configuration as shown in FIG. 8, the
distal end 5230 of the catheter 5200 is advanced substantially past
the peripheral intravenous line 5440. The distal end 5230 of the
catheter 5200 includes a set of openings 5231 such that when in the
second configuration (i.e., when the distal end 5230 of the
catheter 5200 is in the vein and outside the intravenous line) the
openings 5231 act to transport a bodily fluid (i.e., blood) to a
volume outside the catheter 5200. The set of openings 5231 can be
of any arrangement on the circumference of the catheter 5200 and
can include the end of the catheter 5200. Similarly stated, the
catheter 5200 having the distal end 5230 can be substantially open
at the tip surface. Each opening 5231 can be of any suitable shape
or size and are not necessarily similar to any other opening
included in the set of openings. The catheter 5200, in the second
configuration and having transported the desired bodily fluid, can
be placed in a third configuration (e.g., substantially similar to
the first configuration shown in FIG. 7), thereby isolating the
used distal end 5230.
[0102] While the introducer 5100 (FIGS. 7 and 8) is described as
being configured to be substantially compressed to advance the
catheter 5200, in other embodiments, an apparatus can include an
actuator configured to move the catheter relative to the
introducer. For example, FIGS. 9-14 illustrate an apparatus 6000
used for phlebotomy through a peripheral intravenous line. The
apparatus 6000 includes an introducer 6100, a cannula 6200, and an
adapter 6400. The apparatus 6000 can be any suitable shape, size,
or configuration and is configured to be coupled to, for example, a
peripheral intravenous line (PIV) 6300.
[0103] The introducer 6100 includes a proximal end 6120 and a
distal end 6130. As shown in FIGS. 9-14, the introducer 6100 is a
substantially cylindrical tube configured to receive the cannula
6200. Similarly stated, the introducer 6100 includes a wall or set
of walls that define a lumen 6113 (FIG. 11) configured to
selectively receive the cannula 6200. The introducer 6100 and
cannula 6200 can be formed from any suitable material having any
given durometer. In some embodiments, the cannula 6200 can have a
durometer between 20 Shore A and 50 Shore D. In other embodiments,
the cannula 6200 can have a Shore durometer of approximately 20
Shore A to 95 Shore D. In still other embodiments, the cannula 6200
can have a Shore durometer of approximately 70 Shore D to 85 Shore
D.
[0104] The proximal end 6120 of the introducer 6100 is configured
to be coupled to an end cap 6140. In this manner, the end cap 6140
can be configured to substantially close off and/or seal the
proximal end 6120 of the introducer 6100. In some embodiments, the
end cap 6140 is configured to form a substantially fluid-tight seal
with the introducer 6100. Similarly stated, in some embodiments,
the end cap 6140 and the proximal end 6120 of the introducer 6100
define a substantially hermetic seal. In some embodiments, the end
cap 6140 can be grasped by a user as the cannula 6200 is
advanced.
[0105] The distal end 6130 of the introducer 6100 is coupled to a
lock mechanism 6131. The lock mechanism 6131 is configured to
physically and fluidically couple a portion of the apparatus 6000
to the existing PIV 6300. In some embodiments, the lock mechanism
6131 can be configured to be directly coupled to the existing PIV
6300. In other embodiments, the lock mechanism 6131 can be coupled
to the adapter 6400 and/or any other suitable intervening
structure, such as, for example, a known valve or cap.
[0106] The distal end 6130 of the introducer 6100 can be coupled to
the lock mechanism 6131 in any suitable manner. For example, in
some embodiments, the distal end 6130 can be disposed within a
portion of the lock mechanism 6131 such that an outer surface of
the introducer 6100 defines a friction fit with the inner surface
of the portion of the lock mechanism 6131. In other embodiments,
the distal end 6130 of the introducer 6100 can be coupled to the
lock mechanism 6131 via an adhesive. In still other embodiments,
the lock mechanism 6131 can be monolithically formed with the
distal end 6130 of the introducer 6100. For example, in some
embodiments, the lock mechanism 6131 can be formed from a similar
material as the introducer 6100. In other embodiments, the
introducer 6100 can be formed from a first material and the lock
mechanism 6131 can be formed from a second material configured to
be over-molded the distal end 6130 during a manufacturing
process.
[0107] As seen in FIG. 11, the lock mechanism 6131, includes a seal
member 6132 configured to define a substantially fluid tight seal
when the cannula 6200 is in the first configuration. Furthermore,
in use, the seal member 6132 can be configured to receive a portion
of the cannula 6200 to allow the cannula 6200 to advance, in the
distal direction, beyond the seal member 6132. In this manner, the
seal member 6132 can form a substantially fluid tight seal around
the cannula 6200 such that the seal member 6132 substantially
prevents a backflow into the introducer 6100. The seal member 6132
can be any suitable configuration such as, for example, an O-ring,
a one-way valve, a diaphragm, a check valve, or any other suitable
seal member. While shown and described as being included in the
locking mechanism 6131, in some embodiments, a seal member can be
included in the locking mechanism 6131 and/or the adapter 6400. For
example, in some embodiments, the locking mechanism 6131 can be
coupled to the adapter 6400 such that the seal member included in
the adapter 6400 and/or the locking mechanism 6131 prevents a flow
of bodily fluid in the proximal direction prior to advancing the
cannula 6200, as further described herein.
[0108] As seen in FIGS. 10 and 11, the introducer 6100 further
defines an actuator track 6111. The actuator track 6111 can be a
slit or opening defined by the wall of the introducer 6100 and is
configured to receive a portion of the actuator 6500. The actuator
track 6111 can be configured to extend substantially along the
length of the introducer 6100. In some embodiments, the actuator
track 6111 is configured to continuously extend through the distal
end 6130 and the proximal end 6120 of the introducer 6100. The
actuator track 6111 can be any suitable configuration and can
engage the portion of the actuator 6500 in any suitable manner. For
example, in some embodiments, the walls of the introducer 6100
defining the actuator track 6111 can form a friction fit with the
portion of the actuator 6500, as described in further detail
herein.
[0109] The cannula 6200 defines a lumen 6201 (FIG. 11) and is
configured to be movably disposed within the introducer 6100. As
described above with reference to FIG. 5, the cannula 6200 can be
configured to include a first portion 6205 having a first diameter
and a second portion 6210 having a second diameter, smaller than
the first. More specifically, the first portion 6205 is disposed at
a proximal end 6220 of the cannula 6200 and the second portion 6210
is disposed at a distal end 6230 of the cannula 6200. In this
manner, for example, the diameter of the cannula 6200 is reduced at
the distal end 6230 of the catheter 6200 to facilitate the
insertion of the catheter 6200 into the peripheral intravenous
line, as described in further detail herein.
[0110] As described above with reference to FIG. 6A, the distal end
6230 of the cannula 6200 can be configured to include any suitable
number of openings (not shown in FIGS. 9-14. For example, in some
embodiments, the distal end 6230 of the cannula 6200 can include a
substantially open end-surface configured to place the lumen 6201
in fluid communication with, for example, a vein. In some
embodiments, the end surface can be substantially flat (e.g.,
perpendicular to a longitudinal axis of the cannula 6200. In other
embodiments, the end surface can be any suitable configuration such
as, for example, substantially bullet-shaped, conical, bulbous, or
the like. In still other embodiments, the end surface can be
substantially angled with respect to the longitudinal axis of the
cannula 6200 (e.g., similar to the tip of a needle). Furthermore,
in some embodiments, the distal end 6230 can be configured to
include the open end-surface and an opening disposed on the side of
the cannula 6200. In this manner, the side opening (not shown in
FIGS. 9-14) can be configured to transfer a portion of a bodily
fluid even if the opening disposed at the end surface is obstructed
(e.g., by a clot or the like).
[0111] The actuator 6500 is coupled to the proximal end 6220 of the
cannula 6200 and is configured to move the cannula 6200, relative
to the introducer 6100, between a first configuration and a second
configuration. More specifically, the actuator 6500 defines a
substantially annular shape defining a cavity 6510 configured to
receive the proximal end 6120 of the introducer 6100 and the
proximal end 6220 of the cannula 6200. Similarly stated, the
actuator 6500 is disposed about the introducer 6100 and the cannula
6200. Furthermore, the actuator 6500 is configured such that a
guide member 6520 and a coupler 6530 extend from an inner surface
of the actuator 6500.
[0112] The guide member 6520 can be any suitable shape, size, or
configuration. For example, as shown in FIG. 10, the guide member
6520 is a relatively thin extension. In this manner, the guide
member 6520 is disposed within the actuator track 6111 when the
actuator 6500 is disposed about the introducer 6100. In some
embodiments, the walls of the introducer 6100 defining the actuator
track 6111 define a friction fit with a portion of the guide member
6520. The arrangement of the guide member 6520 within the actuator
track 6111 can be such that the actuator 6500 is substantially
maintained in a given location, relative to the introducer 6100,
until a force is applied to the actuator 6500 to move the actuator
6500 towards the second configuration. Similarly stated, the
actuator 6500 engages the introducer 6100 such that the actuator
6500 substantially does not move without a user's intervention
(e.g., applying a force to the actuator 6500). In other
embodiments, the actuator 6500 need not include a guide member
6520. In such embodiments, the actuator 6500 can be configured to
define a friction fit with the introducer 6100 when the actuator
6500 is disposed about the introducer 6100 (e.g., an inner surface
of the wall or walls defining the annular shape of the actuator
6500 engage an outer surface of the introducer 6100 to define the
friction fit).
[0113] The coupler 6530 is disposed on a top surface of the guide
member 6520 (e.g., the guide member 6520 is disposed between the
coupler 6530 and the inner surface of the actuator 6500). As shown
in FIGS. 11 and 13, the coupler 6530 is coupled to the proximal end
6220 of the cannula 6200. In some embodiments, an outer surface of
the proximal end 6220 of the cannula 6200 defines a friction fit
with the inner surface of the coupler 6530. In other embodiments,
the distal end 6220 of the cannula 6200 can be coupled to the
coupler 6530 via an adhesive. In this manner, the proximal end 6220
of the cannula 6200 and the coupler 6530 form a substantially fluid
tight seal.
[0114] A proximal end 6540 of the actuator 6500 is coupled to a
secondary cannula 6250 further configured to be coupled to a
container shroud 6270. The container shroud 6270 defines a cavity
6271 configured to receive fluid reservoir (e.g., a conventional
phlebotomy fluid container such as a Vacutainer.RTM.). More
specifically, secondary cannula 6250 defines a lumen 6253 and
includes a proximal end 6252 configured to be coupled to a lock
mechanism 6524. The lock mechanism 6524 can be configured to be
coupled to the container shroud 6270. In addition, the lock
mechanism 6524 includes a needle 6525 disposed within a sheath 6526
configured to pierce a portion of the fluid reservoir (e.g., as
described above with reference to FIG. 3) when the fluid reservoir
(not shown) is disposed within the container shroud 6270.
Therefore, with the proximal end 6220 of the cannula 6200 coupled
to the coupler 6530 and the secondary cannula 6250 coupled to the
proximal end 6540 of the adapter 6500, the adapter 6500 is
configured to place the cannula 6200 (e.g., the lumen 6201 defined
by the cannula 6200) in fluid communication with the secondary
cannula 6250 (e.g., the lumen 6253 of the secondary cannula 6250)
and the fluid reservoir (not shown).
[0115] While described as including the secondary cannula 6250, in
some embodiments, the apparatus 6000 need not include the secondary
cannula 6250. In such embodiments, the cannula 6200 can define a
continuous fluid path (e.g., lumen 6201) from the distal end 6230,
through the connector 6530, and to the container shroud 6270. In
other embodiments, the container shroud 6270 can be configured to
be physically and fluidically coupled to the actuator 6500.
[0116] The adapter 6400 can be any suitable adapter 6400. For
example, in some embodiments, an adapter can be a known Y-adapter
or T-adapter (e.g., a dual port IV extension set). In other
embodiments, an adapter can be similar in form and function to the
adapter 5400, described above with reference to FIGS. 7 and 8. As
shown in FIG. 10, the adapter 6400 is a T-style adapter and
includes a distal end 6410, a first port 6420, and a second port
6430. The distal end 6410 defines a port and includes a lock
mechanism 6411 configured to be coupled to the peripheral
intravenous line 6300. In this manner, the lock mechanism 6411 can
be any suitable known lock mechanism such that the distal end 6410
of the adapter 6400 can engage a known PIV 6300.
[0117] The first port 6420 can be coupled to a distal end 6427 of
an inlet catheter 6425. In some embodiments, the distal end 6427 of
the inlet catheter 6425 forms a friction fit with an inner surface
of the first port 6420. In some embodiments, the distal end 6427 of
the inlet catheter 6425 can include a fitting configured to engage
the first port 6420 (e.g., a threaded fitting). In other
embodiments, the inlet catheter 6425 can be monolithically formed
with the first port 6420 of the adapter 6400. The inlet catheter
6425 further includes a proximal end 6426 configured to couple to a
lock mechanism 6428. In this manner, the inlet catheter 6425 can be
engaged by a user (e.g., a physician, nurse, or the like) to
administer a fluid (e.g., a medicine or the like) to the peripheral
intravenous line and thus, the vein of a patient. In some
embodiments, the inlet catheter 6425 is substantially similar in
form and function as known inlet catheters. Therefore, with the
adapter 6400 coupled to the PIV 6300 and the PIV 6300 disposed
within a patient, a user can administer a given fluid to the
patient via the inlet catheter 6425 without requiring further
training in the functioning of the adapter 6400.
[0118] In use, a user (e.g., a phlebotomist) can engage the
actuator 6500 of the blood draw apparatus 6000 to move the actuator
6500 in the distal direction, as indicated by the arrow EE in FIG.
12. In this manner, the actuator 6500 moves in the distal direction
relative to the introducer 6100 to place the apparatus in the
second configuration. As described above, the user can apply a
sufficient amount of force to the actuator 6500 such that the
friction between the walls of the introducer 6100 and the guide
member 6520 of the actuator 6500 is overcome. With the cannula 6200
coupled to the coupler 6530 of the actuator 6500, the cannula 6200
is moved in the distal direction concurrently with the actuator
6500 toward the second configuration.
[0119] As indicated by the arrow FF in FIG. 13, the cannula 6200 is
advanced through the seal member 6132 included in the lock
mechanism 6131, through a lumen 6401 defined by the adapter 6400
and through the PIV 6300 such that the distal end 6230 of the
cannula 6200 extends beyond the PIV 6300. In this manner, the
distal end 6230 of the cannula 6200 is substantially disposed
within the vein of the patient such that the lumen 6201, defined by
the cannula 6200, is in fluid communication with the vein. As shown
in FIG. 13A, the cannula 6200 can be advanced through the PIV 6300
such that a distal surface 6206 of the first portion 6205 of the
cannula 6200 is placed in contact with a proximal surface 6301 of a
portion of the PIV 6300. Thus, the distal surface 6206 of the
cannula 6200 engages the proximal surface 6301 of the PIV 6300 to
prevent the cannula 6200 from being advanced beyond the second
configuration. Similarly stated, the distal surface 6206 is
configured to contact the proximal surface 6301 of the portion of
the PIV 6300 to limit the travel of the cannula 6200. While the
first portion 6205 and the second portion 6210 of the cannula 6200
shown in FIG. 13A include a substantially similar inner diameter,
in other embodiments, the first portion 6205 can have a
substantially larger inner diameter than the second portion 6210.
In some embodiments, an inner wall or a set of inner walls that
define the lumen 6201 can include a tapered transition between the
first portion 6205 and the second portion 6210. In other
embodiments, the inner wall or walls need not include a tapered
portion.
[0120] While not shown in FIG. 13, a fluid container (e.g., a
Vacutainer.RTM.) can be disposed within the cavity 6271 defined by
the container shroud 6270 such that the sheath 6256 is withdrawn
from the needle 6255 and the needle 6255 pierces the fluid
container, thereby placing the fluid container in fluid
communication with the vein of the patient. In other embodiments,
the fluid container can be monolithically formed with the container
shroud 6270 and/or with the introducer such that the movement of
the actuator 6500 can urge the needle 6255 to pierce the fluid
container. In some embodiments, the fluid container is configured
to define a negative pressure (e.g., a Vacutainer.RTM.). In such
embodiments, when the needle 6255 pierces the fluid container, the
negative pressure within the fluid container introduces a suction
force within the lumen 6253 of the secondary cannula 6250 and the
lumen 6201 of the cannula 6200. The suction force is such that a
bodily fluid (e.g., blood) is drawn through the lumen 6201 of the
cannula 6200 and the lumen 6253 of the secondary cannula 6250 and
into the fluid container, as indicated by the arrow GG in FIG. 13.
In this manner, a phlebotomist can collect (e.g., draw) a given
amount of blood through an existing peripheral intravenous line
without the need for additional needle sticks.
[0121] With the desired amount of bodily fluid collected, the user
(e.g., phlebotomist) can move the actuator 6500 in the proximal
direction, thereby placing the apparatus 6000 in a third (used)
configuration, as indicated by the arrow HH in FIG. 14. In the
third configuration, the cannula 6200 is substantially fluidically
isolated from a volume outside the introduce 6100. Therefore, the
introducer 6100 (e.g., the lock mechanism 6131) can be decoupled
from the second port 6430 of the adapter 6400 and safely
discarded.
[0122] While the apparatus 6000 (shown and described with respect
to FIGS. 9-14) includes a single piece introducer 6100, in some
embodiments, an apparatus can include a multi-piece introducer
configured for telescopic motion. For example, FIGS. 15-22
illustrate an apparatus 7000 according to an embodiment. As shown
in FIGS. 15-17, the apparatus 7000 includes an introducer 7100 and
a cannula 7200 and is configured to be moved between a first
configuration (FIG. 15) and a second configuration (FIGS. 16 and
17), as described in further detail herein.
[0123] The introducer 7100 includes a first member 7150 defining a
first lumen 7155 and a second member 7160 defining a second lumen
7165. In some embodiments, the first member 7150 is a substantially
cylindrical tube having a first diameter and the second member 7160
is a substantially cylindrical tube having a second diameter,
larger than the first diameter. In this manner, the lumen 7165
defined by the second member 7160 is configured to receive at least
a portion of the first member 7155. More specifically, the first
member 7150 is movably disposed within the second member 7165 such
that the introducer 7100 can be moved in a telescopic motion.
Similarly stated, the second member 7160 is configured to move
between a first position and a second position, relative to the
first member 7150. Furthermore, the second member 7160 includes an
actuator portion 7500 configured to be engaged by a user (e.g., a
phlebotomist) to move the second member 7160 relative to the first
member 7150.
[0124] The introducer 7100 includes a proximal end 7120 and a
distal end 7130. The proximal end 7120 includes a port 7121. The
port 7121 can be any suitable port. For example, in some
embodiments, the port 7121 is substantially similar to the port
1121, described above with reference to FIGS. 1 and 2. In this
manner, the port 7121 is configured to receive a portion of the
catheter 7200, as described in further detail herein. The distal
end 7130 can be coupled to a lock mechanism 7131. The lock
mechanism 7131 can be any suitable mechanism such as, for example,
a Luer Lok.TM.. In some embodiments, the lock mechanism 7131 can be
substantially similar to the lock mechanism 6131 described above
with reference to FIGS. 9-14. Therefore, the lock mechanism 7131 is
not described in further detail herein.
[0125] The introducer 7100 is configured to receive at least a
portion of the cannula 7200. More specifically, the cannula 7200
includes a proximal end 7220 and a distal end 7230 and is at least
partially disposed within the introducer 7100 such that the
proximal end 7220 of the cannula 7200 extends through the port 7121
of the introducer 7100. In this manner, the cannula 7200 is
configured to move relative to at least a portion of the introducer
7100 between a first configuration and a second configuration, as
further described herein.
[0126] The proximal end 7220 of the cannula 7200 is coupled to a
lock mechanism 7221. The lock mechanism 7221 can be any suitable
lock mechanism, such as, for example, a Luer Lok.TM.. Furthermore,
the lock mechanism 7221 is coupled to a needle 7222 such that when
the proximal end 7220 of the cannula 7200 is coupled to the lock
mechanism 7221, a lumen (not shown in FIGS. 15-22) defined by the
cannula 7200 is placed in fluid communication with a lumen (not
shown in FIGS. 15-22) defined by the needle 7222. The distal end
7230 of the cannula 7200 includes a first portion 7205, having a
first diameter, and a second portion 7210, having a second
diameter, smaller than the first diameter. As shown in FIG. 17, the
cannula 7200 is configured to include a taper between the first
portion 7205 and the second portion 7210. The taper can be any
suitable configuration and can be substantially similar to the
taper portion 4203 described above with reference to FIG. 5.
[0127] As shown in the exploded view of FIG. 18, the lock mechanism
7131 is configured to be coupled to an adapter 7400. The adapter
includes a distal end 7410, a first port 7420, and a second port
7430. The adapter 7400 can be any suitable adapter described
herein. For example, in some embodiments, the adapter can be
substantially similar to the adapter 6400 described above with
reference to FIGS. 9-14. In other embodiments, the adapter 7400 can
be any known adapter, such as, for example, a Y-adapter or a
T-adapter. In this manner, the first port 7420 of the adapter 7400
is configured to be coupled to an inlet catheter 7425. The inlet
catheter 7425 can be any suitable configuration. In some
embodiments, the inlet catheter 7425 is substantially similar in
form and function to the inlet catheter 6425 described above with
reference to FIGS. 9-14. Therefore, the inlet catheter 7425 is not
described in detail herein.
[0128] The second port 7430 is configured to be coupled to the lock
mechanism 7131. In this manner, the second port 7430 and the lock
mechanism 7131 can be configured to form a substantially fluid
tight seal. For example, in some embodiments, the second port 7430
can include a threaded coupling configured to engage a threaded
coupling of the lock mechanism 7131, thereby defining the
substantially fluid tight seal. Furthermore, the lock mechanism
7131 can include a seal member (not shown in FIGS. 15-22)
configured to selectively fluidically isolate a lumen 7113 defined
by the introducer 7100 from a lumen (not shown) defined by the
adapter. For example, in some embodiments, the seal member can be
substantially similar in form and function to the seal member 6132
described above with reference to FIG. 11. The distal end 7410 of
the adapter 7400 is configured to be coupled to a peripheral
intravenous line (PIV) 7300. In some embodiments, the PIV 7300 is a
known PIV. In this manner, the distal end 7410 of the adapter 7400
can include any suitable feature configured to physically and
fluidically couple the adapter 7400 to the PIV 7300.
[0129] As shown in FIG. 19, the apparatus 7000 can be in the first
configuration such that he second member 7260 of the introducer
7100 is disposed in a proximal position relative to the first
member 7150 of the introducer 7100. In use, a user (e.g., a
phlebotomist) can engage the actuator 7500 included in the second
member 7160 of the introducer 7100 and move the second member 7160
in the distal direction, as indicated by the arrow II in FIG. 20.
In this manner, the introducer 7100 moves in a telescopic motion
such that the second member 7160 moves relative to the first member
7150. Similarly stated, an overall length of the introducer 7100 is
reduced when the second member 7160 moves relative the first member
7150. Furthermore, the distal movement of the second member 7160 is
such that the cannula 7200 is moved in the distal direction. In
this manner, the distal end 7230 of the cannula 7200 passes through
the seal member included in the lock mechanism 7131 (as similarly
described above in reference to FIGS. 11 and 13) and through the
PIV 7300. As shown in the enlarged view of FIG. 22, the distal end
7230 of the cannula 7200 extends beyond the PIV 7300 to place a
lumen (not shown) defined by the cannula 7200 in fluid
communication with a portion of a body of a patient (e.g., a vein).
Furthermore, in some embodiments, the adapter 7400 can be
configured to include a seal member 7470 configured to receive the
cannula 6200. In this manner, the seal member 7470 can prevent a
backflow of a bodily fluid into, for example, the introducer
7100.
[0130] With the apparatus 7000 in the second configuration (e.g.,
FIGS. 20-22), the user can dispose a fluid container (e.g., a
Vacutainer.RTM., or any other suitable fluid container) within a
container shroud 7270 such that the container engages the needle
7222. In this manner, the needle 7222 can pierce a portion of the
fluid container (not shown) to place the fluid container in fluid
communication with the lumen defined by the cannula 7200. In
addition, with the distal end 7230 of the cannula 7200 disposed
within, for example, the vein of the patient, the fluid container
can be placed in fluid communication with the vein. In some
embodiments, such as those where the fluid container is a
Vacutainer.RTM. or the like, the fluid container can define a
negative pressure (e.g., the fluid container is an evacuated
container). In such embodiments, the negative pressure defined by
the fluid container can introduce a suction force to the lumen
defined by the cannula 7200 such that a bodily fluid (e.g., blood)
is drawn through the cannula 7200 and into the fluid container. In
this manner, a phlebotomist can collect (e.g., draw) a given amount
of blood through an existing peripheral intravenous line without
the need for additional needle sticks.
[0131] While the apparatus 7000 described above with reference to
FIGS. 15-22 includes an introducer 7100 with a first member 7150
and a second member 7160, in some embodiments, an apparatus can
include an introducer with any suitable number of portions or
members. For example, FIGS. 23 and 24 illustrate an apparatus 8000
according to an embodiment. The apparatus 8000 includes at least an
introducer 8100 and a cannula or catheter 8200 and is configured to
be moved between a first configuration (FIG. 23) and a second
configuration (FIG. 24).
[0132] The introducer 8100 includes a first member 8150, a second
member 8160, and a third member 8170. In some embodiments, the
first member 8150 can have a first diameter, the second member 8160
can have a second diameter, larger than the first diameter, and the
third member 8170 can have a third diameter, larger than the second
diameter. In this manner, at least a portion of the first member
8150 can be movably disposed within the second member 8160.
Similarly, at least a portion of the second member 8160 can be
movably disposed within the third member 8170. In this manner, the
introducer 8100 can be configured to be moved in a telescopic
motion, as similarly described above with respect to the introducer
7100.
[0133] As shown in FIGS. 23 and 24, the first member 8150 includes
a set of protrusions 8156 disposed at a proximal end 8151 and a
distal end 8152 of the first member 8150. The second member 8160
similarly includes a set of protrusions 8166 and a set of grooves
8167 disposed at a proximal end 8161 and a distal end 8162 of the
second member 8160. In a similar manner, the third member 8170
includes a set of grooves 8177 disposed at a proximal end 8171 and
a distal end 8172 of the third member 8170. The set of protrusions
8156 and 8166 are configured to selectively engage the set of
grooves 8167 and 8177, respectively, as described in further detail
herein.
[0134] The introducer 8100 includes a proximal end 8120 and a
distal end 8130. The proximal end 8120 is configured to receive a
portion of the catheter 8200. More specifically, the catheter 8200
is movably disposed within the introducer 8100 such that a proximal
end 8220 extends through the proximal end 8120 of the introducer
8100. The distal end 8130 of the introducer 8100 is coupled to a
lock mechanism 8131. The lock mechanism 8131 can be any suitable
lock mechanism described herein. Therefore, the lock mechanism 8131
is not described in further detail.
[0135] The catheter 8200 includes the proximal end 8220 and a
distal end 8230. As described above, the proximal end 8220 is
configured to extend through the proximal end 8120 of the
introducer 8100 when the catheter 8200 is disposed within the
introducer 8100. The proximal end 8220 is coupled to a lock
mechanism 8221. The lock mechanism 8221 is further coupled to a
needle 8222 and a sheath 8223. The lock mechanism 8221, the needle
822, and the sheath 8223 can be substantially similar in form and
function to the lock mechanism 2221, the needle 2222, and the
sheath 2223, respectively, described above with reference to FIG.
3. Therefore, the lock mechanism 8221, the needle 8222 and the
sheath 8223 are not further described herein.
[0136] As shown in FIG. 23, the apparatus 8000 can be in the first
configuration such that the introducer 8100 is in a non-collapsed
configuration. Similarly stated, the third member 8170 of the
introducer 8100 is in a proximal position, relative to the second
member 8160, and the second member 8160 is in a proximal position,
relative to the first member 8150. Expanding further, in the first
configuration, the grooves 8167 disposed at the distal end 8162 of
the second member 8160 are in contact with the protrusions 8156
disposed at the proximal end 8151 of the first member 8150.
Similarly, the grooves 8177 disposed at the distal end 8172 of the
third member 8170 are in contact with the protrusions 8166 disposed
at the proximal end 8161 of the second member 8160. The arrangement
of the protrusions 8156 and 8166 within the grooves 8167 and 8177,
respectively, is such that the introducer 8100 is maintained in the
non-collapsed (e.g., extended or telescoped configuration).
Furthermore, the protrusions 8156 and 8166 can form a friction fit
with a surface defining the grooves 8167 and 8177. In this manner,
the introducer 8100 can be maintained within the first
configuration until an external force is applied to the introducer
8100 to move the introducer towards the second configuration.
[0137] For example in use, a user (e.g., a phlebotomist) can engage
the introducer 8100 and apply a given force, as indicated by the
arrow JJ in FIG. 24. In this manner, the applied force can be such
that the third member 8170 moves in the distal direction relative
to the second member 8160. Similarly, the second member 8160 is
moved in the distal direction relative to the first member 8150
(e.g., the applied force is sufficiently large to overcome the
friction force between the protrusions 8156 and 8166 and the
surface defining the grooves 8167 and 8177, respectively).
Therefore, the introducer 8100 is moved to the second configuration
in which the introducer 8100 is substantially collapsed or
compressed. Furthermore, the relative distal movement of the third
member 8170 and the second member 8160 is such that the set of
grooves 8167 at the proximal end 8161 and the distal end 8162 of
the second member 8160 engage the set of protrusions 8156 at the
proximal end 8151 and the distal end 8152, respectively, of the
first member 8150. Similarly, the set of grooves 8177 at the
proximal end 8171 and the distal end 8172 of the third member 8170
engage the set of protrusions 8166 at the proximal end 8161 and the
distal end 8162 of the second member 8160.
[0138] In this manner, the introducer 8100 is in the second
configuration and the set of protrusions 8156 and 8166 engage the
surfaces defining the set of grooves 8167 and 8177 to define a
friction fit. Thus, the introducer 8100 is maintained in the second
configuration. Furthermore, the telescopic motion of the introducer
8100 is such that the catheter 8200 disposed within the introducer
8200 is advanced through the lock mechanism 8131, as shown in FIG.
24. As described herein, the lock mechanism 8131 can be coupled to
any suitable adapter and/or peripheral intravenous line. Therefore,
when in the second configuration, the catheter 8200 extends beyond
the PIV to draw a portion of a bodily fluid, as described herein
(e.g., similar to the apparatus 7000 described herein with
reference to FIGS. 15-22).
[0139] While the apparatus 6000 described above with reference to
FIGS. 9-14 includes an annular shaped actuator 6500, in some
embodiments, an apparatus can include any suitable actuator. For
example, FIGS. 25 and 26 illustrate an apparatus 9000 according to
an embodiment, in a first configuration and a second configuration,
respectively. The apparatus 9000 includes an introducer 9100, a
cannula 9200, and an actuator 9570. The introducer 9100 includes a
proximal end 9120 and a distal end 9230 and defines a lumen 9113.
The distal end 9230 is configured to be coupled to a lock mechanism
9131. The cannula 9200 includes a proximal end 9220 and a distal
end 9230 and defines a lumen 9201. The introducer 9100 and the
cannula 9200 can be substantially similar in form and function to
any introducer and cannula/catheter described herein. Therefore,
the introducer 9100 and the cannula 9200 are not described in
further detail herein.
[0140] As shown in FIG. 25, the actuator 9570 can be configured to
be a stylet or wire. In this manner, the actuator 9570 can be
movably disposed within the cannula 9200. Furthermore, the actuator
9570 can be sufficiently stiff such as to advance the cannula 9200
through the introducer 9100, the lock mechanism 9131, and an
existing PIV (not shown in FIGS. 25 and 26) substantially without
kinking or creasing. The actuator 9570 can be configured to be
moved in the proximal direction relative to the cannula 9200, as
indicated by the arrow KK in FIG. 26. In this manner, the actuator
9570 can be removed from the cannula 9200 and the cannula 9200 can
be placed in fluid communication with a fluid container. Thus, the
cannula 9200 can facilitate a transfer of a bodily fluid from a
patient to the fluid container, as described above.
[0141] While the embodiments described herein have included an
introducer, in some embodiments, an apparatus need not include an
introducer. For example, FIGS. 27 and 28 illustrate an apparatus
10000 according to an embodiment, in a first configuration and a
second configuration, respectively. The apparatus 10000 can include
a cannula or catheter 10200 with a proximal end 10220 and a distal
end 10230. The cannula 10200 can be substantially similar in form
and function to any cannula/catheter described herein. For example,
in some embodiments, the proximal end 10220 includes a lock
mechanism 10221, a needle 10222, and a sheath 10223, substantially
similar to the lock mechanism 2221, the needle 2222, and the sheath
2223 described above with respect to FIG. 3.
[0142] The catheter 10200 is coupled to a handle 10590 configured
to be engaged by a user (e.g., a phlebotomist). The apparatus 10000
can further include a lock mechanism 10131. The lock mechanism
10131 can be substantially similar in form and function to the lock
mechanism 6131 described above with reference to FIG. 11.
Therefore, in use, a user can couple the lock mechanism 10131 to a
peripheral intravenous line (PIV) 10300 and define a fluid tight
seal. With the lock mechanism 10131 coupled to the PIV 10300, the
user can engage the handle 10590 coupled the catheter 10200 to
advance the catheter 10200 through the lock mechanism 10131 and the
PIV 10300, as indicated by the arrow LL in FIG. 28. Thus, the
catheter 10200 can be placed in fluid communication with a fluid
container and with the catheter 10200 extended beyond the PIV
10300, the catheter 10200 can facilitate a transfer of a bodily
fluid from a patient to the fluid container, as described
above.
[0143] While specific cannulas or catheters are described herein as
including a distal end of a particular configuration (i.e., with
circumferential openings, etc.), in some embodiments the distal end
of the catheter or cannula can include a different structure
configured to facilitate the drawing of blood through the catheter.
For example, FIG. 29 illustrates a catheter 11200 that includes a
distal end 11230 with a bullet-shaped tip 11232. The bullet-shaped
tip 11232 includes an end portion 11233 that defines a single
opening 11234 at a distal end surface of the bullet-shaped tip.
[0144] In some embodiments, such as, for example, a catheter 11200'
shown in FIG. 30, a bullet-shaped tip 11232' includes an end
portion 11233' that defines an end opening 11234'. In such
embodiments, the bullet-shaped tip 11232' includes a set of
side-wall openings 11231'. The end opening 11234' and the side
openings 11231' can be configured to produce a laminar flow and act
to transport a bodily fluid (i.e., blood) to a volume outside the
catheter 11200'. While the openings 11231, 11231', 11234, and
11234' are illustrated as having a particular configuration, the
shape and orientation/relative position of the openings can be
varied to facilitate the fluid flow through the catheter.
[0145] As shown in FIG. 31 the bullet-shaped tip 11232'' can be
configured to include a substantially closed rounded end portion
11233''. In this manner, the bullet-shaped tip 11232'' can be used
to move through clots existing within a peripheral intravenous
line. The bullet-shaped tip 11232'' includes a set of sidewall
openings 11231'' that are operative to transport a bodily fluid
(i.e., blood) to a volume outside the catheter 11200''.
[0146] In some embodiments, for example as shown in FIGS. 32-34, a
catheter 12200 includes a distal end 12230 with a wireframe tip
12241 having a stent-like configuration. The wireframe tip 12241
can be a flexible mesh configured to extend away from the distal
end 12230 of the catheter 12200. The wireframe tip 12241 can act to
transport a bodily flow (i.e., blood) to a volume outside the
catheter 12200. In some embodiments, the wireframe tip 12241 can
include a capped end 12242. The capped end 12242 can be any
suitable size, shape, or configuration and, in some embodiments,
can include any suitable number of openings.
[0147] In some embodiments, the wireframe tip 12241 can be
connected to a guide wire 12243 and used without an additional
catheter, as shown in FIGS. 35-37. Similarly stated, the wireframe
tip 12241 can be inserted into an existing peripheral intravenous
line via a guide wire and without the catheter of FIG. 10. In this
manner, the wireframe tip 12241 can act as a stent and support the
walls of the vein such that blood can be drawn through the existing
peripheral intravenous line. In such a configuration, the wireframe
tip 12241 can be positioned within the existing peripheral
intravenous line at any suitable location. For example, the
wireframe tip can be positioned adjacent the distal end of the
intravenous line.
[0148] As described above with reference to FIGS. 9-14, the blood
draw apparatus 6000 can be coupled to the adapter 6400 which is
further coupled to the PIV 6300. As stated, the adapter 6400 can be
any suitable adapter. For example, in some embodiments, an adapter
13400 can be any of the adapters 13400 shown in FIGS. 38-43. In
such embodiments, the adapters 13400 can be dual port adapters such
as Y-adapters or T-adapters. In such embodiments, the adapters
13400 can include any suitable locking mechanisms, valves, coupling
members, seal members, and/or the like, described herein.
[0149] While FIGS. 38-43 illustrate dual port adapters 13400, in
some embodiments, an adapter can include a single port. For
example, in some embodiments, an adapter 14400 can be either
adapter 14400 shown in FIGS. 44 and 45. In such embodiments, the
adapter 14400 includes a single port configured to administer a
fluid and/or withdraw a fluid to or from the body.
[0150] FIG. 46 is a flowchart illustrating a method for drawing
blood through a peripheral intravenous line. In some embodiments, a
method 100 includes coupling an introducer sheath to a peripheral
intravenous line (PIV), at 102. For example, in some embodiments,
the introducer sheath can include a locking mechanism disposed at a
distal end portion configured to engage a known PIV. In this
manner, the locking mechanism can physically and fluidically couple
at least a portion of the introducer with the PIV. In some
embodiments, an adapter is disposed between the PIV and the locking
mechanism.
[0151] The introducer sheath is configured to house, at least
partially, a catheter. The method 100 further includes advancing
the catheter from a first position, in which the catheter is
substantially within the introducer, to a second position in which
the catheter is substantially outside the introducer, at 104. For
example, in some embodiments, the catheter is at least operatively
coupled to an actuator such that a user can engage the actuator to
move the catheter in a distal direction, relative to the
introducer. Thus, the catheter moves in the distal direction and
can be advanced through the locking mechanism, the adapter (if
present), and the PIV. Furthermore, the catheter can be advanced
such that a distal end of the catheter extends beyond the PIV and
into a portion of a patient (e.g., a vein).
[0152] The method 100 includes coupling a container to a proximal
end of the introducer sheath such that the container is fluidically
coupled to the catheter, at 106. In some embodiments, a proximal
end of the catheter includes a needle configured to pierce a
portion of a fluid container, such as, for example, a
Vacutainer.RTM.. In this manner, the catheter is placed in fluid
communication with the fluid container. More specifically, with the
catheter disposed within, for example, a vein of the patient, the
fluid container is placed in fluid communication with the vein. In
this manner, a desired amount of a bodily fluid (e.g., blood) can
be drawn from the patient and stored in the fluid container.
[0153] With the desired amount of bodily fluid collected, the
method 100 can include withdrawing the catheter from the second
position towards the first position, at 108. In this manner, the
catheter can be moved in the proximal direction such that the
distal end of the catheter is again disposed within the introducer.
With the distal end of the catheter disposed within the introducer,
the introducer and/or the locking mechanism can be configured to
fluidically isolate the catheter from a volume outside the
introducer. Thus, the introducer and catheter can be safely
disposed of without concern of spreading fluid borne pathogens.
[0154] FIGS. 47-68 illustrate an apparatus 15000 (also referred to
herein as a fluid transfer device) according to another embodiment.
The fluid transfer device 15000 can be any suitable shape, size, or
configuration and can be coupled to a PIV (not shown in FIGS.
47-68), for example, via an adapter and/or locking mechanism. As
described in further detail herein, the fluid transfer device 15000
can be manipulated to advance a catheter through an existing and/or
placed PIV (i.e., when the fluid transfer device 15000 is coupled
thereto) such that at least an end portion of the catheter is
disposed in a distal position relative to the PIV. Moreover, with
peripheral intravenous lines each having a shape, size, and/or
configuration that can vary based on, for example, a manufacturer
of the PIV and/or its intended usage, the fluid transfer device
15000 can be arranged to allow the fluid transfer device 15000 to
be coupled to a PIV having any suitable configuration and
subsequently, to advance at least a portion of a catheter through
the PIV substantially without kinking, snagging, breaking, and/or
otherwise reconfiguring the catheter in an undesirable manner.
[0155] As shown in FIG. 47, the fluid transfer device 15000
includes an introducer 15100, a catheter 15200, an actuator 15570,
and an adapter 15450. The adapter 15450 can be any suitable adapter
such as, for example, a Y-adapter or a T-adapter. For example, in
this embodiment, the adapter 15450 is a T-adapter including a first
port 15451 coupled to the introducer 15100, a second port 15452
coupled to a cannula 15455, which in turn, is coupled to a coupler
15456, and a third port 15453 that can be coupled to the PIV (not
shown). In some embodiments, the ports 15451, 15452, and 15453 can
be and/or can include a Luer Lok.TM. or the like that can
fluidically seal the ports 15451, 15452, 15453 when the adapter
15450 is not coupled to a device (e.g., the fluid transfer device
15000, a PIV, etc.). In some embodiments, the adapter 15450 can be
substantially similar to any of the adapters described in detail
above (e.g., the adapters 6400, 7400, and/or 13400). As such, the
adapter 15450 is not described in further detail herein.
[0156] The introducer 15100 of the fluid transfer device 15000
includes a first member 15150 and a second member 15160. The
introducer 15100 can be any suitable shape, size, or configuration.
For example, in some embodiments, the introducer 15100 can be
disposed in and/or can have a substantially telescopic arrangement
such as those described above with reference to the apparatus 7000
and/or 8000. In some embodiments, the introducer 15100 can have a
shape that is, for example, similar to a syringe or the like. As
shown in FIGS. 47-52, the first member 15150 includes a proximal
end portion 15151, a distal end portion 15152, and an inner surface
15153. The inner surface 15153 defines an inner volume 15155 and a
channel 15157. As shown in FIG. 48, the first member 15150 includes
a first half 15150A and a second half 15150B, which can be coupled
together (e.g., via ultrasonic welding, an adhesive, a mechanical
fastener, one or more tabs, snaps, pins, and/or the like) to form
the first member 15150. In some embodiments, coupling the first
half 15150A to the second half 15150B (e.g., during a manufacturing
process) to form the first member 15150 can facilitate a process of
manufacturing the first member 15150. For example, in some
embodiments, forming the first member 15150 from the first half
15150A and the second half 15150B can reduce undesirable variations
in the shape and/or size of the inner surface 15153 (e.g., due to
draft angles and/or manufacturing tolerances) during manufacturing,
which can in some instances, reduce a likelihood of kinks, bends,
and/or deformations of the catheter 15200 during use of the fluid
transfer device 15000.
[0157] In other embodiments, a first member 15150 can be
monolithically formed (e.g., via injection molding and/or any other
suitable manufacturing process). That is to say, the first member
15150 can be formed from a single work piece or the like rather
than two work pieces namely, the first half 15150A and the second
half 15150B. Thus, when referring to features of the first member
15150, such features can be formed and/or defined by the first half
15150A, formed and/or defined by the second half 15150B,
collectively formed and/or defined by the first half 15150A and the
second half 15150B, or, when the first member 15150 is formed from
a single work piece, formed and/or defined by a corresponding
portion of the first member 15150. For example, in this embodiment,
the first half 15150A and the second half 15150B collectively form
the proximal end portion 15151, the distal end portion 15152, and
the inner surface 15153 of the first member 15150.
[0158] As shown in FIGS. 49 and 50, the proximal end portion 15151
of the first member 15150 includes an engagement flange 15159
extending in a radial direction from an outer surface of the first
member 15150. The arrangement of the engagement flange 15159 can
allow a user to engage the engagement flange 15159 to manipulate a
portion of the fluid transfer device 15000, as described in further
detail herein. The distal end portion 15152 of the first member
15150 includes and/or is otherwise coupled to a locking mechanism
15131. The locking mechanism 15131 can be substantially similar to
any of those described herein. In some embodiments, the locking
mechanism 15131 can be a Luer Lok.TM. or the like. As such, a first
end of the locking mechanism 15131 is coupled to the distal end
portion 15152 of the first member 15150 and a second end, opposite
the first end, is coupled to the adapter 15450 (e.g., the first
port 15451). Alternatively, in some instances, the second end of
the locking mechanism 15131 can be coupled directly to the PIV (not
shown in FIGS. 47-68).
[0159] As shown in FIG. 50, the lock mechanism 15131 includes a
seal member 15190 that is in contact with, for example, a distal
surface of the first member 15150 to define a substantially fluid
tight seal. In use, the seal member 15190 can receive a portion of
the second member 15160 to allow the portion of the second member
15160 and/or the cannula 15200 to be advanced beyond the seal
member 15190 in the distal direction while maintaining a
substantially fluid tight seal around the portion of the second
member 15160, thereby substantially preventing a backflow of fluid
into the introducer 15100. The seal member 15190 can be any
suitable configuration such as, for example, an O-ring, a one-way
valve, a diaphragm, a self-healing diaphragm, a check valve, or any
other suitable seal member such as those described herein. While
shown and described as being included in the locking mechanism
15131, in some embodiments, a seal can be included in the locking
mechanism 15131, the adapter 15450, and/or the first member 15150,
as described above. Moreover, the seal member 15190 can contact the
portion of the second member 15160 in such a manner that a friction
force is defined therebetween. In some instances, the friction
force is sufficient to selectively limit movement of the second
member 15160 relative to the first member 15150, as described in
further detail herein.
[0160] As shown in FIGS. 50-52, the first member 15150 includes a
set of annular walls or the like, which form the inner surface
15153. The inner surface 15153 can define a cross-sectional area
with any suitable shape and/or size. For example, a cross-sectional
area defined by the inner surface 15153 (i.e., the cross-sectional
area of the inner volume 15155) can be substantially circular with
a size that is sufficient to receive at least a portion of the
second member 15160, the catheter 15200, and/or the actuator 15570.
Thus, the inner volume 15155 defined by the inner surface 15153 can
be substantially cylindrical with a size that is sufficient to
receive at least a portion of the second member 15160. That is to
say, the inner surface 15153 can have a diameter and/or a perimeter
that is larger than a diameter and/or perimeter of an outer surface
of the second member 15160, as described in further detail herein.
While shown and described as being substantially cylindrical, in
other embodiments, the inner volume 15155 can have any suitable
shape and/or size. For example, in some embodiments, the inner
surface 15153 can define a substantially D-shaped cross-sectional
area (e.g., semi-circular). In other embodiments, the inner surface
15153 can have a cross-sectional shape that is varied along a
length of the first member 15150.
[0161] As described above, the inner surface 15153 defines the
channel 15157. The channel 15157 extends along a length of the
first member 15150 between the proximal end portion 15151 and the
distal end portion 15152, as shown in FIG. 50. More particularly,
the arrangement of the channel 15157 as defined by the inner
surface 15153 is such that the channel 15157 does not extend
through the proximal end portion 15151 or the distal end portion
15152. In other words, the channel 15157 does not extend the entire
length of the first member 15150. Thus, at least a distal end
portion the channel 15157 is bounded by the inner surface 15153. In
addition, the channel 15157 is in fluid communication with the
inner volume 15155. Said another way, the channel 15157 can be
included in and/or otherwise encompassed by the inner volume 15155.
Said yet another way, the inner surface 15153 can define a volume
that includes a first portion (e.g., the inner volume 15155) and a
second portion (e.g., the channel 15157).
[0162] As shown in FIGS. 51 and 52, the arrangement of the inner
surface 15153 can be such that the channel 15157 has a first
cross-sectional area CA.sub.1 at or near the proximal end portion
15151 of the first member 15150 (FIG. 51) and a second
cross-sectional area CA.sub.2 at or near a distal end portion 15152
of the first member 15150 (FIG. 52). For example, in some
embodiments, the channel 15157 can be configured to fan-out, flare,
and/or otherwise widen along a length of the first member 15150 in
the distal direction. As described in further detail herein, a
portion of the second member 15160 can be disposed in the channel
15157 and a portion of inner surface 15153 defining the channel
15157 can define, for example, a range of motion associated with
the second member 15160 relative to the first member 15150.
[0163] As shown in FIGS. 53 and 54, the second member 15160 of the
introducer 15100 includes a proximal end portion 15161, a distal
end portion 15162, an outer surface 15163 having a first protrusion
15164, and an inner surface 15168 having a second protrusion 15169.
The second member 15160 also includes and/or is otherwise coupled
to a guide member 15180. The second member 15160 can have any
suitable shape, size, or configuration. For example, as shown in
FIG. 53, the second member 15160 can have a substantially
cylindrical shape. That is to say, the outer surface 15163 of the
second member 15160 defines and/or has a substantially circular
cross-sectional shape. In some embodiments, the size and/or shape
of the second member 15160 can be associated with and/or can
substantially correspond to the size and/or shape of the inner
surface 15153 of the first member 15150. Thus, at least a portion
of the second member 15160 can be inserted into the first member
15150 and can be movable therein between, for example, a proximal
position and a distal position (e.g., a telescopic motion).
[0164] As described above with reference to the first member 15150,
the second member 15160 includes a first half 15160A and a second
half 15160B, which can be coupled together (e.g., via ultrasonic
welding, an adhesive, a mechanical fastener, one or more tabs,
snaps, pins, and/or the like) to form the second member 15160. In
other embodiments, the second member 15160 can be monolithically
formed (e.g., via injection molding and/or any other suitable
manufacturing process). Thus, when referring to features of the
second member 15160 it should be understood that such features can
be formed and/or defined by the first half 15160A, formed and/or
defined by the second half 15160B, collectively formed and/or
defined by the first half 15160A and the second half 15160B, or,
when the second member 15160 is formed from a single work piece,
formed and/or defined by a corresponding portion of the second
member 15160. For example, in this embodiment, the first half
15160A and the second half 15160B collectively form the proximal
end portion 15161 and the distal end portion 15162 of the second
member 15160.
[0165] The inner surface 15168 of the second member 15160 defines
an inner volume 15165. The inner surface 15168 can define a
cross-sectional area with any suitable shape and/or size. For
example, a cross-sectional area defined by the inner surface 15168
(i.e., the cross-sectional area of the inner volume 15165) can have
a substantially circular cross-sectional shape with a size that is
sufficient to receive at least a portion of the actuator 15570
(e.g., the size is larger than a cross-sectional size of at least a
portion of the actuator 15570). As shown in FIG. 54, the second
member 15160 can include a seal member 15167 disposed in a distal
most position within the inner volume 15165 and about a portion of
the guide member 15180. As such, the seal member 15167 forms a
substantially fluid tight and/or substantially hermetic seal about
the guide member 15180. The seal member 15167 can be any suitable
shape, size, and/or configuration. For example, in some
embodiments, the seal member 15167 can be formed from a flexible
material such as silicone, rubber, and/or any other suitable
elastomeric material. In some embodiments, the seal member 15167
can be configured to absorb a bodily fluid that might otherwise
flow in the proximal direction into the inner volume 15165 (e.g., a
flow of bodily fluid substantially outside of the catheter 15200).
For example, in some embodiments, the seal member 15167 can be
formed from an absorbent material such as POREX.RTM. or the like.
Moreover, the second protrusion 15169 extends from the inner
surface 15168, for example, at or near the proximal end portion
15161 of the second member 15160. As described in further detail
herein, the second protrusion 15169 can engage a portion of the
actuator 15570 when the actuator 15570 is disposed within the inner
volume 15165.
[0166] The first protrusion 15164 of the second member 15160
extends from the outer surface 15163 at or near the distal end
portion 15162 of the second member 15160. Said another way, the
first protrusion 15164 extends in a radial direction from the outer
surface 15163. As such, when the second member 15160 is disposed
within the inner volume 15155 of the first member 15150, the first
protrusion 15164 is disposed in the channel 15157, as shown in FIG.
55.
[0167] The arrangement of the introducer 15100 is such that when
the second member 15160 is moved relative to the first member
15150, the first protrusion 15164 is moved within the channel
15157. As such, the channel 15157 (and/or the portion of the inner
surface 15153 defining the channel 15157) defines a range of motion
for the second member 15160 relative to the first member 15150. For
example, with the channel 15157 extending along the length of the
first member 15150 from the proximal end portion 15151 to the
distal end portion 15152, the range of motion associated with the
second member 15160 as defined by the channel 15157 includes an
axial motion (e.g., a distal and/or proximal direction) of the
second member 15160 within the first member 15150 between its
proximal position and its distal position. Similarly, the increased
width associated with the second cross-sectional area CA.sub.2 can
define, for example, a rotational range of motion about a
longitudinal centerline CL of the first member 15150 (see e.g.,
FIG. 55), as described in further detail herein.
[0168] In some embodiments, the range of motion associated with a
rotation of the second member 15160 (also referred to herein as
"rotational range of motion") is dependent on an axial position of
the second member 15160 along the longitudinal centerline CL of the
first member. For example, in some embodiments, the inner surface
15153 defining a portion of the channel 15157 can be, for example,
relatively tapered or the like such that the rotational range of
motion continuously increases until the second member 15160 is
disposed in a distal position relative to the first member 15150.
In other embodiments, the inner surface 15153 can include any
number of steps or rings with each step or ring being associated
with a portion of the channel 15157 corresponding to a discrete
rotational range of motion. By way of example, the inner surface
15153 can include a first ring associated with a rotational range
of motion of about 30 degrees, a second ring distally adjacent to
the first ring and associated with a rotational range of motion of
about 90 degrees, and a third ring distally adjacent to the second
ring and associated with a rotational range of motion of about 180
degrees.
[0169] With the channel 15157 not extending through the proximal
end portion 15151 or the distal end portion 15152 of the first
member 15150 (as described above), the axial movement of the second
member 15160 relative to the first member 15150 is limited to a
length of the channel 15157. Thus, at least a portion of the second
member 15160 is maintained in the inner volume 15155 and
substantially prevented from being retracted therethrough.
Furthermore, a portion of the inner surface 15153 defining a
proximal end portion of the channel 15157 can include, for example,
a rib 15158 (e.g., a ridge, a protrusion, a bump, etc.) that can be
configured to at least temporarily maintain the first protrusion
15164 and thus, the second member 15160 in the proximal position
relative to the first member 15150, as described in further detail
herein.
[0170] Referring back to FIGS. 53 and 54, the guide member 15180
includes a proximal end portion 15181 and a distal end portion
15182. The proximal end portion 15181 is coupled to and/or
otherwise extends from the distal end portion 15162 of the second
member 15160. More specifically, the proximal end portion 15181 of
the guide member 15180 is disposed within the seal member 15167,
which in turn, is disposed in the inner volume 15165 of the second
member 15160. As shown in FIG. 54, at least a portion of the seal
member 15167 is disposed in a proximal position relative to the
guide member 15180. In other words, the proximal end portion 15181
of the guide member 15180 does not extend through the seal member
15167 disposed within and/or coupled to the distal end portion
15162 of the second member 15160, as described in further detail
herein.
[0171] In this embodiment, the guide member 15180 can be, for
example, a cannula, a catheter, and/or the like. As such, the guide
member 15180 defines a lumen 15183 that movably receives a portion
of the catheter 15200. As described in further detail herein, the
arrangement of the second member 15160 and the guide member 15180
is such that when the second member 15160 is disposed in the
proximal position relative to the first member 15150, the guide
member 15180 is disposed in the first member 15150 and when the
second member 15160 is moved to the distal position relative to the
first member 15150, the distal end portion 15182 of the guide
member 15180 at least partially extends beyond, for example, a
distal end of a PIV (not shown). Moreover, the second member 15160
is disposed in the inner volume 15155 of the first member 15150 in
such a manner that the guide member 15180 extends through the seal
member 15190. Thus, the seal member 15190 is in contact with an
outer surface of the guide member 15180 to define the substantially
fluid tight seal, as described above.
[0172] The guide member 15180 can be formed from any suitable
material with a stiffness sufficient to allow the guide member
15180 to be passed through a hub of a PIV substantially without
kinking, breaking, and/or otherwise plastically deforming. For
example, in some embodiments, the guide member 15180 can be a metal
hypotube or the like with a hardness (e.g., intrinsic to the
material used to form the guide member 15180) and/or a stiffness
(e.g., dependent on both material, size, and shape of the guide
member 15180) sufficient to allow the guide member 15180 to pass
through any suitable hub configuration included in a PIV as the
second member 15160 is moved from the proximal position to the
distal position. As described in further detail herein, the guide
member 15180 can be advanced through at least a portion of an PIV
so that the distal end portion 15182 is in a distal position
relative to at least the hub or basket of the PIV and once placed
in a desired position, the catheter 15200 can be advanced within
the lumen 15183 defined by the guide member 15180 in the distal
direction so that at least a portion of the catheter 15200 is
disposed distal to the guide member 15180. Thus, the arrangement of
the guide member 15180 and the catheter 15200 limits and/or
substantially prevents a kinking, bending, breaking, pinching,
and/or other form of deformation of the catheter 15200 as the
catheter 15200 is moved in the distal direction.
[0173] Although the guide member 15180 is shown and described as
being a cannula, catheter, and/or hypotube, in other embodiments, a
guide member can be any suitable configuration. For example, in
some embodiments, a guide member can be an elongate structure with
a substantially V-shaped or U-shaped cross-section. Such a guide
member can, for example, define a channel or the like configured to
receive and/or guide a portion of a catheter. In other embodiments,
the guide member 15180 can be a braided wire, a conduit, a coil, a
spiral, a rail, and/or any other suitable member configured to
receive and/or guide a portion of a catheter. Thus, the arrangement
and/or configuration of the guide member 15180 can be associated
with an amount of stiffness sufficient to allow the guide member
15180 to be passed through a PIV and/or sufficient to guide the
catheter 15200 to reduce, for example, a likelihood of the catheter
15200 being kinked when being moved within the introducer
15100.
[0174] As shown in FIGS. 56-60, the actuator 15570 of the fluid
transfer device 15000 includes a proximal end portion 15571 and a
distal end portion 15572 and defines a slot 15573. The proximal end
portion 15571 includes an engagement portion 15579 that can be
substantially similar to the engagement portion 15159 of the first
member 15150. For example, a user can engage the engagement portion
15579 to manipulate at least the actuator 15570 of the fluid
transfer device 15000, as described in further detail herein. The
proximal end 15540 is coupled to a secondary cannula 15250 that
includes a coupler 15254, which in turn, is configured to be
coupled to a fluid reservoir (e.g., a Vacutainer.RTM. or the like
(not shown in FIGS. 47-68)). As described in further detail herein,
the actuator 15570 is coupled to the catheter 15200 such that when
the coupler 15254 is coupled to the fluid reservoir, the catheter
15200 is placed in fluid communication with the fluid
reservoir.
[0175] The actuator 15570 can have any suitable shape, size, or
configuration. For example, as shown in FIG. 56, the second member
15160 can have a substantially cylindrical shape. In some
embodiments, the size and/or shape of the second member 15160 can
be associated with and/or can substantially correspond to the size
and/or shape of the inner surface 15168 of the second member 15160.
In this manner, at least a portion of the actuator 15570 can be
inserted into the inner volume 15165 defined by the second member
15160 and can be moved there in between, for example, a proximal
position and a distal position (e.g., a telescopic motion). More
specifically, as shown in FIGS. 59 and 60, the actuator 15570 can
be disposed within the inner volume 15165 of the second member
15160 in such a manner that the second protrusion 15169 extending
from the inner surface 15168 is disposed within the slot 15573
defined by the actuator 15570. Thus, as the actuator 15570 is moved
in an axial motion (e.g., in the distal direction or the proximal
direction) relative to the second member 15160, the second
protrusion 15169 is moved within the slot 15573. As described
above, in some embodiments, the actuator 15570 can be disposed
between the first half 15160A and the second half 15160B of the
second member 15160 prior to being coupled. Thus, the second
protrusion 15169 can be inserted into the slot 15573 defined by the
actuator 15570. In other embodiments, the second protrusion 15169
can be movable so as to allow the actuator 15570 to be inserted
into the inner volume 15165, as described above with reference to
the first member 15150.
[0176] In some embodiments, a length of the slot 15573 can define a
range of motion of the actuator 15570 relative to the second member
15160. Moreover, with the slot 15573 not extending through the
proximal end portion 15571 or the distal end portion 15572 of the
actuator 15570 (see e.g., FIGS. 56 and 57), at least a portion of
the actuator 15570 is maintained in the inner volume 15165 and
substantially prevented from being retracted therethrough, as
described with reference to the second member 15160). Furthermore,
a surface of the actuator 15570 defining a distal end portion of
the slot 15573 can include, for example, a protrusion, a ridge, a
rib, a bump, etc. that can be configured to at least temporarily
maintain the first protrusion 15164 in a distal position relative
to the actuator 15570, as shown in FIG. 60. Thus, the actuator
15570 can be maintained in the proximal position relative to the
second member 15160 prior to use, as described in further detail
herein.
[0177] The actuator 15500 is coupled to the catheter 15200 and is
configured to move the catheter 15200, relative to the introducer
15100, between a first configuration and a second configuration, as
described in further detail herein. The catheter 15200 of the fluid
transfer device 15000 has a proximal end 15206 and a distal end
15212 and defines a lumen 15209 therethrough (see e.g., FIGS.
56-62). As described above with reference to FIG. 5, the catheter
15200 includes a first portion 15205 (e.g., a proximal portion)
having a first diameter and a second portion 15210 (e.g., a distal
portion) having a second diameter, smaller than the first (see
e.g., FIG. 56). In some embodiments, the diameter of the catheter
15200 at the second portion 15210 can, for example, facilitate the
insertion of the catheter 15200 into the peripheral intravenous
line, as described in further detail herein. In some embodiments,
the catheter 15200 can be between a 16-gauge and 26-gauge and have
a Shore durometer of about 20 Shore A to about 95 Shore D. In other
embodiments, the catheter 15200 has a Shore durometer of about 20
Shore A to 50 Shore D. In still other embodiments, the catheter
15200 has a Shore durometer of about 70 Shore D to 85 Shore D.
[0178] In some embodiments, the first portion 15205 of the catheter
15200 can have a Shore durometer that is greater than a Shore
durometer of the second portion 15210. For example, in some
embodiments, the first portion 15205 can be formed from a first
material or first blend of materials and the second portion can be
formed from a second material or second blend of materials having a
durometer less than a durometer of the first material or first
blend of materials. In some embodiments, the first portion 15205
and the second portion 15210 can be, for example, co-extruded. In
other embodiments, the first portion 15205 can be, for example,
over-molded about a portion of the second portion 15210. In still
other embodiments, the second portion 15210 can be formed by
drawing an end of the first portion 15205. As such, the first
portion 15205 can have a stiffness and/or durometer that is
sufficient to inhibit a kinking, a pinching, a breaking, and/or an
undesirable plastic deformation of the first portion 15205 while
being advanced, for example, through the introducer 15100, as
described in further detail herein. The second portion 15210 can
have a stiffness and/or durometer that is less than the stiffness
and/or durometer of the first portion 15210 and as such, can be
configured to bend, flex, elastically deform, and/or otherwise
reconfigure, which, in some instances, can reduce a likelihood of
the second portion 15210 puncturing a vascular tissue when disposed
therein and/or allow the second portion 15210 to be advanced
through a kink, bend, turn, valve, and/or obstruction in, for
example, a lumen defined by a PIV, as described in further detail
herein.
[0179] The first portion 15205 of the catheter 15200 is coupled to
the actuator 15570. More specifically, as shown in FIG. 57, the
first portion 15205 of the catheter 15200 extends a length of the
actuator 15570 such that the proximal end 15206 of the catheter
15200 is disposed at or near the proximal end portion 15571 of the
actuator 15570. In this manner, the lumen 15209 defined by the
catheter 15200 is placed in fluid communication with the secondary
catheter 15250, as described in further detail herein. The second
portion 15210 of the catheter 15200 can be arranged in any suitable
manner. For example, in some embodiments, the distal end 15212 of
the catheter 15200 (i.e., disposed at an end of the second portion
15210) can include a substantially open end-surface configured to
place the lumen 15209 in fluid communication with, for example, a
vein. In some embodiments, the distal end 15212 can include the
open end-surface and any number of openings disposed on the side
(e.g., circumference) of the catheter 15200, as described
above.
[0180] As shown in FIG. 62, in this embodiment, the distal end
15212 of the catheter 15200 is angled or beveled. In some
instances, a beveled distal end 15212 can facilitate the
advancement of the catheter 15200 through a kink or bend, for
example, by rotating the catheter 15200 to align a bevel angle with
a kink angle or the like. In other embodiments, the distal end
15212 can be any suitable configuration such as, for example,
substantially flat, bullet-shaped, conical, bulbous, or the like.
In still other embodiments, the distal end 15212 can be
substantially open (as shown in FIG. 62) and can include one or
more slits, cuts, grooves, channels, and/or the like that
substantially traverse a distal surface of the distal end 15212. In
such embodiments, the slits can introduce a discontinuity in and/or
along a portion of the distal end 15212, which in some embodiments
can decrease a stiffness of the distal end 15212 by allowing, for
example, an elastic deformation of the distal end 15212. In some
instances, an elastic deformation (i.e., non-permanent) of the
distal end 15212 can facilitate the advancement of the catheter
15200 past and/or through kinks, bends, corners, etc. within a
vascular structure, a portion of the PIV, and/or the like.
[0181] As shown in FIGS. 60-62, the arrangement of the actuator
15570 and the catheter 15200 is such that when the actuator 15570
is disposed within the second member 15160 of the introducer 15100
at least a portion of the catheter 15200 is disposed in the guide
member 15180. More specifically, when the actuator 15570 is
disposed in the proximal position relative to the second member
15160, the second portion 15210 of the catheter 15200 is disposed
in the guide member 15180. When the actuator 15570 is moved to the
distal position relative to the second member 15160, the second
portion 15210 of the catheter 15200 at least partially extends
beyond the distal end portion 15182 of the guide member 15180, as
described in further detail herein.
[0182] Expanding further, a portion of the catheter 15200 is
disposed in and extends through the seal member 15167 of the second
member 15160. As such, an outer surface of a portion of the
catheter 15200 that is disposed in the seal member 15167 and that
is proximal to the guide member 15180 is in contact with the seal
member 15167 and as such, the seal member 15167 forms a
substantially fluid tight seal with the outer surface of that
portion of the catheter 15200. Thus, with the catheter 15200
disposed in the guide member 15180 and the seal member 15167
forming a substantially fluid tight seal with the distal end
portion 15181 of the guide member 15180 and the portion of the
catheter 15200, the seal member 15167 inhibits and/or substantially
prevents a bodily fluid inside of the guide member 15180 but
outside of the catheter 15200 from flowing into a volume proximal
to the seal member 15167. Simply stated, the seal member 15167 can
engage the guide member 15180 and the catheter 15200 to inhibit
bodily fluid from leaking into a volume proximal to the seal member
15167.
[0183] As shown in FIGS. 59-60, prior to use, the fluid transfer
device 15000 can be disposed in a first configuration (e.g., an
expanded configuration), in which the second member 15160 is
disposed in its proximal position relative to the first member
15150 and the actuator 15570 is disposed in its proximal position
relative to the second member 15160. In this manner, the guide
member 15180 is disposed within the first member 15150 of the
introducer 15100 and at least the second portion 15210 of the
catheter 15200 is disposed within the guide member 15180. Expanding
further, as shown in FIG. 59, the catheter 15200 is at least
partially disposed in the introducer 15100 when the fluid transfer
device 15000 is in the first configuration. In some embodiments,
the inner volume 15165 of the second member 15160 and the inner
volume 15155 of the first member can be substantially fluidically
sealed such that the inner volumes 15165 and 155 are each
substantially sterile. As a result, at least a portion of the
catheter 15200 is maintained in a substantially sterile environment
prior to use.
[0184] While the first portion 15205 of the catheter 15200 is
shown, for example, in FIG. 58 as extending through the slot 15573
of the actuator 15570 and thus, being exposed to an ambient
environment, in other embodiments, the actuator 15570 and/or
catheter 15200 can include a bag, a cover, a wrapper, a sleeve,
and/or the like that can be disposed about the portion of the
catheter 15200 that extends through the slot 15573 of the actuator
15570 to maintain the portion of the catheter 15200 in a
substantially sterile environment. Thus, the first portion 15205
and the second portion 15210 can be substantially sterile prior to
use. In other embodiments, the second member 15160 of the
introducer 15100 can include, for example, a sterilization member
(e.g., a sponge, a wipe, a seal, etc.) disposed within the inner
volume 15160 that can be configured to contact an outer surface of
the catheter 15200, thereby sterilizing a portion of the catheter
15200 when the catheter 15200 is moved relative to the second
member.
[0185] While in the first configuration, a user (e.g., a
phlebotomist) can manipulate the fluid transfer device 15000 to
couple the first member 15150 of the introducer 15100 to the
adapter 15450 (see e.g., FIG. 59). In other embodiments, the fluid
transfer device 15000 can be, for example, pre-assembled with the
adapter 15450. In still other embodiments, the fluid transfer
device 15000 can be used without the adapter 15450. In this
embodiment, the locking mechanism 15131 disposed at the distal end
portion 15152 of the first member 15150 is coupled to the first
port 15451 of the adapter 15450. Although not shown in FIGS. 59-68,
the third port 15453 of the adapter 15450 can be coupled to a PIV.
As a result, the introducer 15100 is coupled (e.g., indirectly via
the adapter 15450 or directly when used without the adapter 15450)
to the PIV. Although not shown in FIGS. 59-68, the coupler 15254
disposed at the end of the secondary cannula 15250 can be coupled
to a fluid reservoir or the like to place the lumen 15209 of the
catheter 15200 in fluid communication with the fluid reservoir.
[0186] Once coupled to the PIV and the fluid reservoir, the user
can engage the engagement portion 15159 of the first member 15150
and the engagement portion 15579 of the actuator 15570 to exert a
force on the actuator 15579. More particularly, by engaging the
engagement portion 15159 of the first member 15150, a portion of
the force exerted on the actuator 15579 that would otherwise be
exerted on the PIV (e.g., via the introducer 15100 and the adapter
15450) can be reduced. Said another way, the user can exert a
reaction force on the engagement portion 15159 of the first member
15150 in response to the force applied to the actuator 15570 which
is sufficient to reduce and/or substantially eliminate a force that
would otherwise be transmitted to and exerted on the PIV.
[0187] The force exerted on the engagement portion 15579 of the
actuator 15570 moves the actuator 15570 and the second member 15160
in the distal direction relative to the first member 15150, thereby
placing the fluid transfer device 15000 in a second configuration,
as indicated by the arrow MM in FIG. 63. More specifically, the
actuator 15570 moves the second member 15160 from its proximal
position to its distal position relative to the first member 15150,
while the actuator 15570 remains in a relatively fixed position
(e.g., its proximal position) relative to the second member 15160.
For example, as described above, a portion of the inner surface
15153 defining a proximal end portion of the channel 15157 can
include, for example, a protrusion, a ridge, a rib, a bump, etc.
that can be configured to at least temporarily maintain the first
protrusion 15164 and thus, the second member 15160 in the proximal
position relative to the first member 15150. Similarly, the rib
15574 of extending from a surface of the actuator 15570 that
defines the slot 15573 at least temporarily maintains the second
protrusion 15169 in a distal position relative to the actuator
15570 and thus, the actuator 15570 is at least temporarily
maintained its proximal position relative to the second member
15160.
[0188] As such, the ribs 15158 and 15574 narrow a portion of the
channel 15157 and the slot 15573, respectively, to a width smaller
than a width of the first protrusion 15164 and the second
protrusion 15169, respectively. Thus, the second member 15160 can
be maintained substantially in the proximal position until a force
is applied (e.g., either directly or indirectly) to the second
member 15160 that is sufficient to move the first protrusion 15164
through the narrowed portion of the channel 15157 (e.g., associated
with the ribs 15158). Thus, in response to a force the first
protrusion 15164 can exert a portion of the force on the ribs 15158
of the inner surface 15153, which in turn, can deform, bend, flex,
and/or reconfigure the inner surface 15153 a sufficient amount to
allow the first protrusion 15164 to pass therethrough (and/or to
otherwise overcome a friction force therebetween). In a similar
manner, the actuator 15570 can be maintained substantially in the
proximal position until a force is applied on the actuator 15570
that is sufficient to move the second protrusion 15169 through the
narrowed portion of the slot 15573 (e.g., associated with the ribs
15574). Thus, in response to a force the second protrusion 15169
can exert a portion of the force on the ribs 15574 of the actuator
15570, which in turn, can deform, bend, flex, and/or otherwise
reconfigure a surface of the actuator 15570 a sufficient amount to
allow the second protrusion 15169 to pass therethrough (and/or to
otherwise overcome a friction force therebetween).
[0189] As shown in FIG. 63, the actuator 15570 and the second
member 15160 are collectively moved relative to the first member
15150 in response to the applied force on the engagement portion
15579 of the actuator 15570. As such, a portion of the force moves
the first protrusion 15164 past and/or through the ribs 15158
extending from the inner surface 15153 of the first member 15150,
while the ribs 15574 of the actuator 15570 retain the second
protrusion 15169 in a substantially fixed position. Thus, a force
sufficient to move the second member 15160 relative to the first
member 15150 is less than a force sufficient to move the actuator
15570 relative to the second member 15160. Such an arrangement can,
for example, ensure that the second member 15160 is relative to the
first member 15150 prior to the actuator 15570 being moved relative
to the second member 15160. In some embodiments, the movement of
the first protrusion 15164 past the ribs 15158 can be, for example,
associated with and/or otherwise result in an indicator such as a
haptic, tactile, visual, and/or auditory output. For example, in
some embodiments, an indicator can be an auditory output such as a
"click." In other embodiments, an indicator can be a visual output
such as indicia, markings, a status window, a change in color of a
status member, a digital output to be presented on a display,
and/or the like.
[0190] As shown in FIG. 64, the movement of the second member 15160
to the distal position relative to the first member 15150 advances
the guide member 15180 (coupled thereto) in the MM direction to a
position in which at least the distal end portion 15182 of the
guide member 15180 is disposed in and extends past an end of the
PIV. More specifically, as the second member 15160 is moved to its
distal position, the guide member 15180 is concurrently advanced
through a port or "basket" of the PIV (not shown). As described
above, the guide member 15180 is configured to have a stiffness
and/or is formed from a material(s) with a hardness or durometer
that is sufficient to pass through the port of the PIV
substantially without kinking, breaking, bending, plastically
deforming (e.g., permanently deforming), etc. Moreover, the guide
member 15180 can have a length and hardness that is sufficient to
pass through any suitable PIV to dispose at least the distal end
portion 15182 in a distal position relative to the end of the PIV.
In other words, the guide member 15180 can be arranged such that
when the second member 15160 is in its distal position relative to
the first member 15150, the distal end portion 15182 of the guide
member 15180 is disposed in a vascular structure and at least
partially outside of the PIV. Furthermore, with the actuator 15570
maintained in a relatively fixed position relative to the second
member 15160, the second portion 15210 of the catheter 15200 is
maintained within the lumen 15183 defined by the guide member
15180, as shown in FIG. 64.
[0191] With the second member 15160 in its distal position, the
applied force exerted on the engagement portion 15579 moves the
actuator 15570 from its proximal position to its distal position
relative to the second member 15160. For example, the second member
15160 can be moved through its range of motion (e.g., defined at
least in part by the channel 15157) to be disposed in its distal
most position and as such, a portion of the applied force that was
exerted to move the second member 15160 relative to the first
member 15150 is instead substantially exerted on the actuator
15570. As such, the force exerted on the actuator 15570 can be
sufficient to move the second protrusion 15169 past the ribs 15574
disposed in the slot 15573 and as a result, the actuator 15570 is
moved from its proximal position to its distal position relative to
the second member 15160, as indicated by the arrow NN in FIG. 65.
In some embodiments, the movement of the actuator 15570 from its
proximal position to its distal position can be associated with
and/or otherwise result in an indicator such as a haptic, tactile,
visual, and/or auditory output, as described above.
[0192] As shown in FIG. 66, the movement of the actuator 15570 to
its distal position relative to the second member 15160 advances
the catheter 15200 in the NN direction to a position in which at
least the distal end portion 15212 of the catheter 15200 is
disposed in and extends past the PIV. Moreover, the catheter 15200
can be advanced such that the distal end portion 15212 of the
catheter 15200 extends beyond the distal end portion 15182 of the
guide member 15180. Thus, the catheter 15200 can be arranged such
that when the actuator 15570 is in its distal position relative to
the second member 15160 and the second member 15160 is in its
distal position relative to the first member 15150, the distal end
portion 15212 of the catheter 15200 is disposed in a vascular
structure and at least partially outside of the PIV and the guide
member 15180. Thus, the lumen 15209 of the catheter 15200 can
receive a flow of bodily fluid, which in turn, can flow through the
lumen 15209 to be disposed in the fluid reservoir. For example, in
some embodiments, the fluid reservoir can be an evacuated reservoir
such as a Vacutainer.RTM., which can exert a suction force through
the lumen 15209 of the catheter 15200. Thus, the bodily fluid
(e.g., blood) is drawn through the lumen 15209 of the cannula 15200
and the lumen 15253 of the secondary cannula 15250 and into the
fluid container. In this manner, a phlebotomist can collect (e.g.,
draw) a given amount of blood through an existing peripheral
intravenous line without the need for additional needle sticks.
[0193] As shown in FIGS. 67 and 68, in some embodiments, it may be
desirable to rotate the catheter 15200 relative to the first member
15150, thereby rotating the distal end 15212 within the vascular
structure (e.g., to prevent a suctioning of the distal end 15212 to
a wall of the vascular structure). Thus, in such instances, the
user can manipulate, for example, the actuator 15570 to rotate the
actuator 15570 and the second member 15160 relative to the first
member 15150. More specifically, the arrangement of the second
protrusion 15169 within the slot 15573 defined by the actuator
15570 can be such that the actuator 15570 is maintained in a
substantially fixed angular position relative to the second member
15160. Thus, manipulation of the actuator 15570 by the user can
result in a rotation of both the actuator 15570 and the second
member 15160 relative to the first member 15150.
[0194] As described above, the channel 15157 can have a
cross-sectional shape and/or area at or near the proximal end
portion 15151 of the first member 15150 that is associated with
and/or slightly larger than a size of the first protrusion 15164,
thereby limiting the rotational range of motion of the second
member 15160 when disposed in the proximal position. With the
second member 15160 in the distal position, however, the
cross-sectional shape and/or area of the channel 15157 at or near
the distal end portion 15152 of the first member 15150 (i.e., the
second cross-sectional area CA.sub.2) can allow the second member
15160 to rotate about 30 degrees, about 60 degrees, about 90
degrees, about 120 degrees, about 180 degrees, about 210 degrees,
or more relative to the longitudinal centerline CL. That is to say,
in some embodiments, the second member 15160 can rotate in a
clockwise motion or a counterclockwise motion about the
longitudinal centerline CL and relative to a center position of the
first protrusion 15164 (see e.g., FIG. 67) in a range between about
0 degrees to about 105 degrees, as indicated by the arrow OO in
FIG. 68.
[0195] In some instances, such rotation of the actuator 15570 and
the second member 15160 can, for example, reduce a likelihood of
the distal end 15212 of the catheter 15200 forming suction against
a wall of the vascular structure (e.g., a vein). For example, by
rotating the catheter 15200 the one or more openings defined by the
distal end 15212 are also rotated, which in turn, can reduce the
likelihood of the distal end 15212 adhering to a wall of the
vascular structure due to a suction force within the catheter 15200
(e.g., via an evacuated fluid reservoir or the like). In some
instances, it may be desirable to rotate the second member 15160 as
the actuator 15570 is being moved toward its distal position. Such
rotation can, in some such instances, facilitate the advancement of
the catheter 15200 by rotating the catheter 15200 such that a
beveled surface or the like (as described above) is aligned with a
kinked surface of the guide member 15180 and/or vascular structure.
In some instances, the alignment of the beveled surface of the
catheter 15200 and the kinked surface can facilitate the passage of
the catheter 15200 though the kinked region.
[0196] In some instances, it may be desirable to move the catheter
15200 in an axial direction relative to the first member 15150
and/or the second member 15160. More specifically, the arrangement
of the second member 15160 and the actuator 15570 is such that the
second protrusion 15169 is disposed within the slot 15573 defined
by the actuator 15570 in a position that is proximal to the
protrusions 15574. Thus, the second protrusion 15169 can move
relatively free within the slot 15563. In some embodiments,
however, the catheter 15200 can be disposed within the guide member
15180 such that a friction force is defined therebetween. As such,
a movement of the actuator 15570 in the axial direction (i.e., the
proximal direction and/or the distal direction) can similarly,
result in an axial movement of the second member 15160 relative to
the first member 15150.
[0197] In other embodiments, it may be undesirable for the second
member 15160 to move concurrently in the axial direction with the
actuator 15570. For example, in some instances, such movement of
the second member 15160 can place the distal end portion 15182 of
the guide member 15180 in an undesired position relative to, for
example, the PIV. In such embodiments, the arrangement of the guide
member 15180 of the second member 15160 and the seal member 15190
of the first member 15150 can, for example, limit and/or
substantially prevent axial movement of the second member 15160
relative to the first member 15150. More specifically, as described
above, the seal member 15190 is disposed about the guide member
15180 and can be in contact therewith to define both a
substantially fluid tight seal as well as an amount of friction. In
some embodiments, the amount of friction (i.e., a friction force)
and/or an amount of drag can be sufficient to limit and/or
substantially prevent an axial movement of the second member 15160
relative to the first member 15150. Thus, the actuator 15570 can be
moved in the axial direction relative to the second member 15160
until a force is exerted on the second member 15160 that is
sufficient to overcome the friction force between the seal member
15190 and the guide member 15180. With the actuator 15570 being a
substantially fixed angular or rotational position relative to
second member 15160, however, at least a portion of a force exerted
to rotate the actuator 15570 is transferred to and/or otherwise
exerted on the second member 15160 and thus, when the force is
sufficient to overcome the friction force between the seal member
15190 and the guide member 15180, the actuator 15570 and the second
member 15180 are rotated relative to the first member substantially
concurrently.
[0198] With the desired amount of bodily fluid collected, the user
(e.g., phlebotomist) can move the actuator 15570 in the proximal
direction to retract the catheter 15200. For example, in some
instances, the user can exert a force on the engagement portion
15579 of the actuator 15570 in the proximal direction, which is
sufficient to move at least the actuator 15570 from its distal
position toward its proximal position relative to the second member
15160. In some embodiments, the second member 15160 can be
configured to be moved at least in part with the actuator 15570
from its distal position toward its proximal position relative to
the first member 15150. In some instances, the force can be
sufficient to place the actuator 15570 and the second member 15160
in their respectively proximal positions. Moreover, the arrangement
of the actuator 15570 and the introducer 15100 is such that the
actuator 15570 is prevented from being removed from the second
member 15160 and the second member 15160 is prevented from being
removed from the first member 15150, as described above. Thus, the
guide member 15180 and the catheter 15200 can be disposed in a
proximal position relative to a distal end of the first member
15150.
[0199] Although the actuator 15570 and the second member 15160 are
described above as being moved in response to a force exerted in
the proximal direction applied by the user, in other embodiments,
the actuator 15570 and/or the second member 15160 can be configured
to move in the proximal direction in an at least semi-automatic
manner. For example, in some embodiments, the introducer 15100 can
include one or more bias members configured to exert a force to
move the second member 15160 and/or the actuator 15570 in the
proximal direction. Expanding further, the bias member can exert a
reaction force in response to the force exerted on the actuator
15579. Thus, once a desire volume of bodily fluid is disposed in
the fluid reservoir, the user can remove the force applied on the
actuator 15570 and as a result, the bias member can exert a force
to move the second member 15160 and the actuator 15570 in the
distal direction. In other embodiments, the introducer 15100 can
include a bias member connected to a retraction mechanism. In such
embodiments, the user can place the second member 15160 and the
actuator 15570 in the respective distal positions and can further
exert a force in the distal direction that can engage the
retraction mechanism (e.g., engages a switch, a lock, a latch, a
tab, a retention member, etc.), which in turn, can actuate the bias
member to exert a force on the second member 15160 and the actuator
15570 in the proximal direction. In some embodiments, the
engagement of the retraction mechanism can be associated with an
indicator such as a haptic, tactile, auditory, and/or visual
output, which can be transitioned from a first state to a second
state during a retraction process, as described above.
[0200] Although the rotational range of motion of the second member
15160 relative to the first member 15150 is shown and described
above as being defined at least in part by the channel 15157, in
other embodiments, the first member 15150 and the second member
15160 of the introducer 15100 can be arranged in any suitable
manner. For example, in some embodiments, the inner surface 15153
of the first member 15150 can have a proximal portion having a
first cross-sectional shape (e.g., substantially D-shaped) and a
distal portion having a second cross-sectional shape different from
the first shape (e.g., substantially circular), while the outer
surface 15163 of the second member 15160 can have a proximal
portion having the second cross-sectional shape and a distal
portion having the second cross-sectional shape. As such, when the
second member 15160 is disposed in a proximal position within the
inner volume 15155 of the first member 15150, the cross-sectional
shapes are substantially aligned, which in turn, can limit a
rotational motion of the second member 15160 relative to the first
member 15150. Conversely, when the second member 15160 is advanced
to a distal position within the inner volume 15155 of the first
member 15150, the cross-sectional shapes are not substantially
aligned, which in turn, can allow for a rotational motion of the
second member 15160 relative to the first member 15150.
[0201] While the introducer 15100 and the actuator 15570 are
particularly shown and described above with reference to FIGS.
47-68, in other embodiments, a device can include an introducer
and/or an actuator of any suitable configuration while maintaining
a substantially similar functionality. For example, FIGS. 69-72
illustrate a first member 16150 included in an introducer (not
shown in FIGS. 69-72) according to another embodiment. As described
above, the first member 16150 includes a proximal end portion
16151, a distal end portion 16152, and an inner surface 16153. The
inner surface 16153 defines an inner volume 16155 and a channel
16157. The distal end portion 16152 of the first member 16150
includes and/or is otherwise coupled to a locking mechanism 16131.
The locking mechanism 16131 can be substantially similar to any of
those described herein. In some embodiments, the locking mechanism
16131 can be a Luer Lok.TM. or the like. As such, a first end of
the locking mechanism 16131 is coupled to the distal end portion
16152 of the first member 16150 and a second end, opposite the
first end, can be coupled to an adapter (e.g., the adapter 15450 in
FIG. 47). Alternatively, in some instances, the second end of the
locking mechanism 16131 can be coupled directly to a PIV (not shown
in FIGS. 69-72).
[0202] As shown in FIG. 50, the lock mechanism 16131 includes a
seal member 16190 that is in contact with, for example, a distal
surface of the first member 16150 to define a substantially fluid
tight seal. In use, the seal member 16190 can receive, for example,
a portion of a second member included in the introducer and/or a
cannula or catheter (e.g., coupled to an actuator) to be advanced
beyond the seal member 16190 in the distal direction while
maintaining a substantially fluid tight seal around the portion of
the second member and/or cannula or catheter, thereby substantially
preventing a backflow of fluid into a volume proximal to the seal
member 16190 (and outside of the second member and/or cannula or
catheter). The seal member 16190 can be any suitable configuration
such as, for example, an O-ring, a one-way valve, a diaphragm, a
self-healing diaphragm, a check valve, or any other suitable seal
member such as those described herein (e.g., the seal member
15190). Moreover, the arrangement of the seal member 16190 can be
such that when in contact with a guide member and/or a catheter, a
desired friction force is defined therebetween. In such
embodiments, the friction force can be configured to resist and/or
otherwise produce drag in response to an applied force that would
otherwise move the guide member (e.g., coupled to a second member
of the introducer, as described above with reference to the
introducer 15100) in a axial direction. As such, the drag produced
by the friction force defined between the seal member 16190 and the
guide member can, for example, maintain the guide member and thus,
a second member of the introducer to which it is coupled, in a
substantially fixed position relative to the first member while
allowing, for example, the catheter and/or an actuator coupled
thereto to move in an axial direction relative to the
introducer.
[0203] As described above, the inner surface 16153 defines the
channel 16157. The channel 16157 extends along a length of the
first member 16150 between the proximal end portion 16151 and the
distal end portion 16152, as shown in FIG. 69. More particularly,
the arrangement of the channel 16157 as defined by the inner
surface 16153 is such that the channel 16157 does not extend
through the distal end portion 16152. In other words, at least a
distal end portion the channel 16157 is bounded by the inner
surface 16153. Thus, the channel can function in a similar manner
as described above with reference to the first member 15150.
[0204] As shown in FIGS. 69 and 70, a proximal end portion of the
channel 16157 can extend in a circumferential direction. More
particularly, in some embodiments, the proximal end portion of the
channel 16157 can form a dogleg 16157A and/or can be substantially
L-shaped. In this manner, a portion of the channel 16157 disposed
at and/or near the end of the doglegged portion 16157 can extend
through the proximal end portion 16151 of the first member 16150.
That is to say, the proximal end portion 16151 of the first member
16150 can define a substantially circular opening (i.e., associated
with the inner volume 16155), which can include a notched portion
16157B or key-holed portion corresponding with an end portion of
the dogleg 16157A of the channel 16157. Thus, a limited portion of
the channel 16157 can extend through the proximal end portion 16151
of the first member 16150. Similarly stated, the channel 16157 can
be substantially enclosed and/or bounded by the inner surface
except for the notched portion 16157B.
[0205] In some embodiments, such an arrangement can allow, for
example, a second member of the introducer (e.g., substantially
similar to the second member 15160 of the introducer 15100) to be
inserted into the first member 16150. In some embodiments, the
second member can include a protrusion (e.g., similar to or the
same as the first protrusion 15164 of the second member 15160) that
is inserted through, for example, the notched portion 16157B and/or
key-holed opening corresponding to the doglegged portion 16157A of
the channel 16157 (as described above). Once the protrusion s
inserted therethrough, the second member can be rotated or clocked
to an orientation relative to the first member in which the
protrusion is substantially aligned with a portion of the channel
16157 that extends from the proximal end portion 16151 of the first
member 16150 to the distal end portion 16152 of the first member
16150. Thus, with the second member in such an orientation, a
proximal movement of the second member relative to the first member
16150 is thereby limited. Accordingly, the first member 16150 can
function in a substantially similar manner as the first member
15150 described in detail above.
[0206] In a similar manner, FIGS. 73-76 illustrate an actuator
16570 according to another embodiment. The actuator 16570 includes
a proximal end portion 16571 and a distal end portion 16572 and
defines a slot 16573. The proximal end 16540 is coupled to a
secondary cannula 16250, which in turn, is configured to be coupled
to a fluid reservoir (e.g., a Vacutainer.RTM. or the like (not
shown in FIGS. 73-76)). As described in detail above with reference
to the actuator 15570 and the catheter 15200, the actuator 16570 is
coupled to the catheter 16200 such that when the secondary cannula
16250 is coupled to the fluid reservoir, the catheter 16200 is
placed in fluid communication with the fluid reservoir.
[0207] As described above, the actuator 16570 is configured to be
inserted into a second member of an introducer (not shown in FIGS.
73-76). For example, in some embodiments, the actuator 16570 can be
inserted into a second member that is substantially similar to or
the same as the second member 15160 described above. As such, the
second member can include an inner protrusion (e.g., the second
protrusion 15169), which can be disposed within the slot 16573.
More particularly, as shown in FIGS. 75 and 76, the actuator 16570
can include an opening 16578 that can be configured to provide
access to the slot 16573. In some embodiments, a distal end portion
of the slot 16573 can include a doglegged portion (e.g., as
described above with reference to the first member 16150) such that
the slot 16573 extends through a side and/or portion of the
circumference of the actuator 16570. Thus, the actuator 16570 can
be partially disposed in the second member and oriented such that
the opening 16578 is aligned with the inner protrusion. Once the
inner protrusion is inserted therethrough, the actuator 16570 can
be rotated or clocked to an orientation relative to the second
member in which the inner protrusion is substantially aligned with
a portion of the slot 16573 channel that extends from the proximal
end portion 16571 of the actuator 16570 to the distal end portion
16572 of the actuator 16570. Thus, with the actuator 16570 in such
an orientation, a proximal movement of the actuator relative to the
second member is thereby limited. Accordingly, the actuator 16570
can function in a substantially similar manner as the actuator
15570 described in detail above.
[0208] Referring to FIG. 69, a flowchart is shown illustrating a
method 200 of phlebotomy through a peripheral intravenous line,
according to another embodiment. The method includes coupling a
fluid transfer device to a peripheral intravenous line (PIV), 201.
The fluid transfer device can be any suitable device configured for
phlebotomy through a PIV. For example, in this embodiment, the
fluid transfer device can be substantially similar to the fluid
transfer device 15000 described above with reference to FIGS.
47-68. As such, the fluid transfer device includes an introducer,
an actuator, and a catheter. The introducer includes a first member
and a second member movably disposed within the first member, as
described above with reference to FIGS. 48-55. The second member is
coupled to a guide member. The actuator is movably disposed in the
second member and is coupled to the catheter.
[0209] A first force is exerted on the actuator that is sufficient
to move the second member relative to the first member from a first
position, in which a guide member coupled to the second member is
disposed within the first member, to a second position, in which a
distal end portion of the guide member is inserted through a port
of the PIV, at 202. More particularly, the force exerted on the
actuator moves the actuator and the second member in the distal
direction relative to the first member, while the actuator remains
in a relatively fixed position (e.g., a proximal position) relative
to the second member. For example, in some embodiment, the second
member can be configured to move relative to the first member in
response to a first amount of force and the actuator can be
configured to move relative to the second member in response to a
second amount of force, greater than the first amount of force. For
example, in some embodiment, the first member can selectively
engage a portion of the second member to temporarily retain the
second member in the first position relative to the first member.
Similarly, the second member can selectively engage a portion of
the actuator to temporarily retain the actuator in a first position
relative to the second member, as described in detail above.
Furthermore, the guide member can have a length and a hardness that
are each sufficient to allow the guide member to pass through the
port of the PIV substantially without kinking, breaking, and/or
otherwise plastically deforming.
[0210] With the second member in the second position (e.g., a
distal position), a second force is exerted on the actuator that is
sufficient to move the actuator relative to the second member such
that a distal end portion of the catheter extends past an end of
the peripheral intravenous line, at 203. More specifically, the
catheter can be at least partially disposed in the introducer prior
to the actuator being moved relative to the second member such that
at least a distal end portion of the catheter is disposed in the
guide member. Therefore, with the actuator coupled to the catheter,
the movement of the actuator relative to the second member moves
the catheter relative to the guide member. In this manner, when the
actuator is in a distal position relative to the second member, the
catheter can extend through the PIV and the guide member to dispose
the distal end portion of the catheter in a distal position
relative to the guide member and the PIV, as described above with
reference to FIGS. 65 and 66.
[0211] In some instances, it may be desirable to rotate the second
member and/or the actuator relative to the first member as the
actuator and/or the second member are being moved relative to the
first member. For example, as described above in some embodiments,
the first member can define a channel configured to receive a
portion of the second member. In this manner, a surface defining
the channel can define, for example, a range of motion associated
with the second member relative to the first member. As described
above with reference to FIGS. 51, 52, 67, and 68, the channel can
define the range of motion of the second member relative to the
first member that can include, for example, a translational
movement (e.g., in a proximal or distal direction) and a rotational
movement. In some instances, a portion of the first force and/or a
portion of the second force can rotate the second member and the
actuator relative to the first member. Such rotation can, for
example, facilitate the advancement of the guide member and/or the
catheter through a portion of the PIV and/or the like. In other
instances, a force can be exerted on the actuator when the distal
end portion of the catheter extends past the end of the PIV to
limit a suctioning of the distal end portion of the catheter to a
vascular structure in which it is disposed. Thus, the catheter can
be rotated to reduce the likelihood of the distal end portion of
the catheter suctioning to a wall of the vascular structure within
which it is disposed and/or to facilitate the advancement of the
catheter past an obstruction included within the guide member, the
PIV, and/or the vascular structure.
[0212] A fluid reservoir is coupled to the fluid transfer device,
at 204. The fluid reservoir can be any suitable reservoir. For
example, in some embodiments, the fluid reservoir can be an
evacuated reservoir such as a Vacutainer.RTM. or the like.
Moreover, when the fluid reservoir is coupled to the fluid transfer
device, the catheter is placed in fluid communication with the
fluid reservoir. Thus, a bodily fluid can flow (e.g., in response
to a negative pressure and/or suction force) from the body, through
the catheter, and into the fluid reservoir. In some instances,
while withdrawing a volume of bodily fluid, it can be desirable to
move at least the distal end portion of the catheter in an axial
direction to, for example, limit and/or substantially prevent a
suctioning of the distal end portion of the catheter to, for
example, the vascular structure in which it is disposed. In this
manner, the user can exert a force in the distal direction to
correspondingly advance the catheter in the distal direction or can
exert a force in the proximal direction to correspondingly retract
the catheter in the proximal direction (e.g., while still being
disposed distal to the PIV). Moreover, in some embodiments, the
first member of the introducer can include a seal member and/or the
like that can engage, for example, the guide member coupled to the
second member of the introducer. In such embodiments, the seal
member can contact the guide member such that a friction force
sufficient to maintain the second member in a substantially fixed
position as the catheter is moved in the distal or proximal
direction is defined therebetween. Thus, the catheter and thus, the
actuator can be moved relative to the introducer.
[0213] After a volume of bodily fluid is transferred to the fluid
reservoir, the catheter is withdrawn from the PIV and disposed
within the introducer, at 205. For example, in some instances, a
third force is exerted on the actuator. The third force can be, for
example, exerted in the proximal direction and can be which is
sufficient to move at least the actuator from a distal position
toward a proximal position relative to the second member. In some
embodiment, the third force can be exerted by a user. In other
embodiments, the third force can be exerted, for example, by a bias
member or the like in response to an actuation, as described above.
In some embodiments, the second member can be configured to be
moved at least in part with the actuator from a distal position
toward a proximal position relative to the first member. Moreover,
the arrangement of the actuator and the introducer is such that the
actuator is prevented from being removed from the second member and
the second member is prevented from being removed from the first
member, as described above. Thus, the guide member and the catheter
can be disposed in a proximal position relative to a distal end of
the first member. In some instances, on the catheter and the guide
member are disposed in the proximal position relative to the distal
end of the first member, the fluid transfer device can be
discarded.
[0214] The components of the blood draw apparatus and the Y-adapter
can be packaged together or separately. The Y-adapter can also be
sold in a package with other IV dressing materials. In some
embodiments, the Y-adapter can remain on the IV as long as the IV
is in the patient.
[0215] The blood draw apparatus can be used with a variety of
peripheral IVs. The apparatus allows efficient blood draw while
still maintaining the integrity of the sample. In some embodiments,
for example, the apparatus will facilitate 20 ml of blood to be
drawn in approximately 1-2 minutes. While extracting blood, the
blood flow can be laminar to avoid turbulence in the catheter,
thereby minimizing hemolysis.
[0216] While the blood draw apparatus can be used in a variety of
settings (ER, in-patient, etc.), two examples of scenarios are
described herein. In the first scenario, the patient has a single
peripheral IV. In the second scenario, which is typically less
common, the patient has a dedicated second peripheral IV just for
phlebotomy purposes. Only one y-adapter is required per patient,
and can be attached for the life of the IV, for example, which is
typically 3-4 days. A new blood draw apparatus (e.g., any of those
described above) can be used for each blood draw.
[0217] The assembly of the blood draw apparatus can be the same in
either scenario. First, the apparatus is coupled to the y-adapter.
Second, the catheter is advanced through the y-adapter and pushed
through the peripheral IV catheter into the patient's vein. Once in
the vein, a syringe or a negative pressure collection
container/tube (e.g., a Vacutainer.RTM. tube) is connected to the
rear port and fluidically coupled to the catheter to draw and store
blood.
[0218] The following scenario is provided by way of example. The
nurse or phlebotomist inserts a peripheral IV into a patient's arm.
The peripheral IV is inserted following standard guidelines and the
y-adapter is attached. When it is time to draw blood, the provider
can turn off the IV, if it is on, for approximately 1-5 minutes to
allow medicine or IV fluids to disperse from the blood-drawing
site. To draw the blood sample, the provider attaches the blood
draw apparatus to the blood draw port on the y-adapter, advances
the internal catheter through the peripheral IV and into the vein.
Next, the provider can attach the negative pressure collection
container(s)/tube(s) to the apparatus (i.e., place the tube in
fluid communication with the blood draw apparatus) to extract the
blood sample. In use, a user can discard, for example, the first
3-6 ml of the fluid or blood sample as "waste" then using the next
tube(s) as the intended sample. This "wasting" procedure ensures
all of the dead space fluid, like saline or medications, is cleared
from the vein, peripheral IV and y-adapter as to not contaminate
the testing sample being drawn.
[0219] In the scenario in which there is a dedicated peripheral IV
line for blood draw purposes, the provider inserts a peripheral IV
into one arm to administer medicine and another peripheral IV into
the opposite arm specifically for blood drawing purposes. When it
is time to draw blood, the provider simply follows the steps
mentioned above and there is no need to wait the 1-5 minutes to
allow fluid or medicine dispersal as in the first scenario.
[0220] Each of the components discussed herein can be
monolithically constructed or can be a combination of parts. For
example, in reference to FIG. 7, the y-adapter 5400 and the
introducer 5100 are coupled using locking mechanisms 5431 and 5131,
respectively. The y-adapter 5400 and the introducer 5100 can be the
same component, wherein the y-adapter 5400 is an integral part of
the introducer 5100 and vice-versa. By way of another example,
while the first member 15150 of the introducer 15100 is shown and
described above with reference to FIGS. 48-52 as including the
first half 15150A and the second half 15150B which are, for
example, coupled together during a manufacturing process to form
the first member 15150, in other embodiments, the first member
15150 can be monolithically formed.
[0221] Similarly, the components described herein can be assembled
in any suitable manner during, for example, a manufacturing process
and/or at a point of use. For example, in some embodiments a
manufacturing process associated with the fluid transfer device
15000 (and/or a device substantially similar to thereto) can
include placing the second member 15160 in a desired position
relative to the first half 15150A or the second half 15150B of the
first member 15150 prior to the first half 15150A and the second
half 15150B being coupled together to form the first member 15150.
Thus, the second member 15160 can be disposed between the first
half 15150A and the second half 15150 when the first half 15150A
and the second half 15150B are coupled together and as a result,
the first protrusion 15164 can be disposed in the channel 15157
prior to the first member 15150 being formed, which in some
instances, can facilitate the assembly of the fluid transfer device
15000 based at least in part on the channel 15157 being bounded by
the inner surface 15153.
[0222] In other embodiments, the protrusion 15164 can be, for
example, spring loaded and/or otherwise configured to be moved in
the radial direction relative to the second member 15160. As such,
the first member 15150 can be formed by a manufacturing process
(e.g., by coupling the first half 15150A to the second half 15150B)
and the second member 15160 can be subsequently disposed in the
inner volume 15155. For example, with the first half 15150A being
coupled to the second half 15150B to form the first member 15150,
the second member 15160 can be placed in a desired position
relative to the first member 15150 and the first protrusion 15164
can be moved in a radial direction toward a center of the second
member 15160 such that an end surface of the first protrusion 15164
is disposed substantially adjacent to the outer surface 15163 of
the second member 15160. In this manner, the distal end portion
15162 of the second member 15160 can be inserted into the inner
volume 15155. Moreover, once the second member 15160 is placed in a
position within the inner volume 15155 associated with an alignment
of the first protrusion 15164 and the channel 15157, the first
protrusion 15164 can move in the radial direction away from the
center of the second member 15160 (e.g., in response to a force
exerted by a spring or the like). Thus, the second member 15160
need not be disposed between the first half 15150A and the second
half 15150B prior to the first half 15150A and the second half
15150B being coupled together to form the first member 15150.
[0223] Other aspects of the apparatus shown and described can be
modified to affect the performance of the apparatus. For example,
the openings in the set of openings described herein at the distal
end of the catheter can be in any arrangement, size shape, and/or
number, to create preferable flow conditions through the catheter.
By way of another example, any portion of the catheters described
herein can be disposed within a substantially sterile sleeve, bag,
tube, cover, and/or the like that can maintain the sterility of the
catheter prior to use of the device. In addition, while components
of the embodiments have been described herein as having a given
hardness, durometer, and/or stiffness, in other embodiments, some
components can be substantially rigid. For example, in some
embodiments, the introducer 6100 can be formed from a substantially
rigid material. Similarly, any of the guide tubes and/or members
described herein can be formed from a rigid material such as, for
example, a metal or hard plastic. For example, in some embodiments,
a guide member can be a metal hypotube or the like. In some
embodiments, the arrangement of a catheter (e.g., the catheter
15200) disposed within a lumen defined by a guide member (e.g., the
guide member 15180) can be such that the catheter and the guide
member collectively define a stiffness that is, for example, a sum
of a stiffness of the catheter and a stiffness of the guide member.
Thus, in some embodiments, the guide member can have a stiffness
that is substantially similar to a stiffness of the catheter,
wherein a collective stiffness defined thereby is sufficient to
allow the guide member to pass through at least a portion of a PIV
(e.g., a hub, a basket, or the like).
[0224] By way of another example, any of the catheters, cannulas,
flow tubes, and/or the like described herein can include and/or can
otherwise receive, for example, a guide wire, stiffening wire,
lattice and/or matrix structure, stent, balloon, and/or the like
that can increase a stiffness associated with the catheter and/or
otherwise limit and/or substantially prevent a kinking, pinching,
and/or plastic deformation of at least a portion of the catheter.
For example, in some embodiments, the catheter 15200 can include,
for example, a guide wire or the like that can be disposed in the
lumen 15209 while the catheter 15200 is placed in its distal
position, thereby increasing a stiffness associated with the
catheter 15200. When the distal end 15212 of the catheter 15200 is
in a desired position relative to the PIV (i.e., distal to a distal
end of the PIV), the guide wire can be retracted through the lumen
15209 to be removed from the catheter 15200.
[0225] While the second portion 15210 (e.g., a distal end portion)
of the catheter 15200 is particularly shown and described above, in
other embodiments, a catheter can have a distal end portion with
any suitable configuration. For example, FIG. 78 is a schematic
illustration of a distal end portion 17212 of a catheter, according
to another embodiment. As shown, the distal end portion 17212 of
the catheter can define a channel or the like. Expanding further, a
first portion of the catheter (not shown in FIG. 78) can have, for
example, an annular cross-sectional shape, while a second portion
of the catheter (i.e., the distal end portion 17212) can have, for
example, a semi-annular cross-sectional shape. In other words, the
distal end portion 17212 can be, for example, cut, skived, shaved,
bisected, and/or the like such that the distal end 15212 of the
catheter has a semi-circular or semi-annular cross-sectional shape
that defines a channel therebetween. Such an arrangement of the
distal end portion 17212 can, in some embodiments, allow for a
reduced size and/or gauge associated with the distal end 17212 of
the catheter, which might otherwise be prone to kinks,
obstructions, and/or occlusions. Moreover, the semi-annular
arrangement of the distal end portion 17212 can increase flow rate
through the catheter, which might otherwise be limited due to a
relatively small inner diameter of the catheter and/or a relatively
small distal opening of the catheter.
[0226] In still other embodiments, a distal end portion of a
catheter such as those described herein can include and/or can be
coupled to a wound wire, a braided wire, a coiled and/or spiraled
wire, a helical wire, a mesh, and/or the like. By way of example,
in some embodiments, a distal end portion of a catheter can include
and/or can be formed from a relatively small wound or coiled wire.
In some embodiments, such a wire can be, for example, tightly wound
into a substantially solid cylindrical shape, thereby defining a
portion of a lumen. In some instances, such an arrangement can
allow at least the distal end portion of the catheter to bend
and/or flex substantially without plastically deforming as the
catheter is advanced in the distal direction. In some embodiments,
the wound wire arrangement of the distal end portion can act, for
example, as an auger or the like which can be rotated while being
advanced in the distal direction to remove, clear, and/or break
apart an obstruction such as, for example, a clot. Moreover, while
the catheter 15200 is particularly shown and described above, in
some embodiments, the distal end portion 15212 of the catheter
15200 can have any suitable configuration such as those described
herein.
[0227] While various embodiments have been described above, it
should be understood that they have been presented by way of
example only, and not limitation. Where schematics and/or
embodiments described above indicate certain components arranged in
certain orientations or positions, the arrangement of components
may be modified. While the embodiments have been particularly shown
and described, it will be understood that various changes in form
and details may be made. For example, while the device or apparatus
6000 is shown and described above as including the introducer 6100
with a relatively small actuator track 6111 (e.g., a slit), in
other embodiments, an introducer can be, for example, a
substantially U-shaped channel or the like. In such embodiments, an
actuator and a catheter can be at least partially disposed in the
introducer and moved relative thereto, as described herein.
Moreover, in such embodiments, the catheter can be disposed, for
example, within a sterile bag or sleeve. In other embodiments, the
introducer can be, for example, a guide rail or the like along
which an actuator and catheter can be moved. In such embodiments,
the catheter can be disposed, within a sterile bag or sleeve.
[0228] Although various embodiments have been described as having
particular features and/or combinations of components, other
embodiments are possible having a combination of any features
and/or components from any of embodiments as discussed above. For
example, any of the devices described herein can include an
actuator that can be coupled to a catheter and operable in rotating
a catheter relative to, for example, a PIV or the like. By way of
another example, while the cannula 6200 is shown in FIG. 13A as
including the first portion 6205 having the first diameter and the
second portion 6210 having the second diameter, in some
embodiments, a cannula can include a first portion and a second
portion of similar diameter. Furthermore, while the first member
15150 of the introducer 15100 is particularly shown and described
as including the seal member 15190, in other embodiments, the first
member 15150 can include a seal member substantially similar in
form and function to the seal member 16190 included in the first
member 16150 described above with reference to FIGS. 69-72, or vice
versa. Similarly, the first member 16150 and/or the actuator 16570
(or features included therein) can be included in, for example, the
flow transfer device 15000.
[0229] By way of another example, any of the catheters and/or
cannulas described herein can have a distal end portion with any
suitable arrangement. For example, while the distal end portion
15212 of the catheter 15200 is shown as being substantially
cylindrical with an angled or beveled tip, in other embodiments,
the distal end portion 15212 and/or the second portion 15210 of the
catheter 15200 can have any suitable arrangement. For example, FIG.
79 is a schematic illustration of a distal end portion 18212 of a
catheter according to another embodiment. As shown, the distal end
portion 18212 defines a set of openings 18216 arranged, for
example, in a staggered orientation. More specifically, the second
portion 18210 of the catheter 18200 can define a set of openings
disposed along its circumference similar to the set of openings
1231, 2231, and/or 4231 described above with reference to the
catheters 1200, 2200, and 4200, respectively. In such embodiments,
the set of openings can be substantially circular, oblong,
polygonal, elliptical, and/or any other suitable shape, size, or
arrangement. In this manner, the set of openings 18216 can, for
example, increase flow rate into the distal end portion 18212 of
the catheter, while the staggered and/or offset arrangement of the
set of openings 18212 can allow the distal end portion 18212 to
remain sufficiently stiff as to limit and/or substantially prevent
a collapse of the distal end portion 18212.
[0230] Where methods and/or schematics described above indicate
certain events and/or flow patterns occurring in certain order, the
ordering of certain events and/or flow patterns may be modified.
Additionally certain events may be performed concurrently in
parallel processes when possible, as well as performed
sequentially.
* * * * *